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Reviews of Research on Health-Care Acquired Infections, Glucocorticoid Therapy in COPD, and Blood-Pressure Lowering in Intracerebral Hemorrhages
In This Edition
Literature At A Glance
A guide to this month’s studies
- Perioperative SSRI use associated with adverse surgical outcomes
- Copper-surfaced rooms reduce health-care-acquired infections
- Glucocorticoid therapy for five days not inferior to 14 days for COPD exacerbation
- Patient preference for participation in medical decision-making may be associated with increased resource utilization
- Early parenteral nutrition in critically ill adults does not significantly affect mortality or infection rates
- Aggressive fluid and sodium restriction in acute decompensated heart failure did not improve outcomes
- Lower rate of pacemaker, defibrillator device-pocket hematoma without anticoagulation interruption
- Prophylactic penicillin decreased risk of recurrent leg cellulitis
- Universal ICU decolonization reduced rates of mrsa clinical isolates and bloodstream infection
- Intensive blood-pressure lowering in intracerebral hemorrhage did not reduce death or severe disability
Perioperative SSRI Use Associated with Adverse Surgical Outcomes
Clinical question: Does selective serotonin reuptake inhibitor (SSRI) use during hospitalization for surgery increase the risk of adverse perioperative outcomes?
Background: SSRIs commonly are prescribed but are associated with a small but higher risk for hemorrhage, arrhythmia, and sudden death. Single-site studies have described an association between SSRIs and adverse perioperative outcomes, but larger studies utilizing a broad range of surgical cases are lacking.
Study design: Retrospective cohort study.
Setting: Three hundred hospitals concentrated in the Southern U.S.
Synopsis: Using the “Perspective” database, this study examined 530,416 patients age >18 years undergoing major elective surgery, 72,540 (13.7%) of whom received an SSRI. Regression analysis showed patients receiving an SSRI had higher odds of mortality (OR 1.2, 95% CI [1.07-1.36]), higher odds of 30-day readmission (OR 1.22 [1.18-1.26]), and higher odds for bleeding (1.09 [1.04-1.15]). When the analysis was restricted to only patients with a diagnosis of depression, a higher risk of bleeding and readmission persisted.
This study reaffirms an association but does not establish a causal relationship between SSRI use and adverse perioperative outcomes. SSRI use may be a surrogate for other factors, including more severe mood disorders, poorer functional status, or chronic pain. Additionally, no information has been provided as to optimal duration of withholding SSRIs preoperatively. As such, it may be premature for hospitalists involved in perioperative care to modify recommendations based on this study.
Bottom line: Perioperative SSRI use is associated with an increased risk of bleeding and 30-day readmission.
Citation: Auerbach AD, Vittinghoff E, Maselli J, et al. Perioperative use of selective serotonin reuptake inhibitors and risks for adverse outcomes of surgery. JAMA Intern Med. 2013;173(12):1075-1081.
Copper-Surfaced Rooms Reduce Health-Care-Acquired Infections
Clinical question: Can copper alloy surfaces in ICU rooms lower rates of health-care-acquired infections (HAIs)?
Background: Environmental contamination is a potential source of HAIs. Copper has intrinsic broad-spectrum antimicrobial properties. This study tests the efficacy copper-surfaced items in hospital rooms have in preventing HAIs.
Study design: Randomized controlled trial.
Setting: Medical ICUs at Medical University of South Carolina and Ralph H. Johnson Veterans Affairs Medical Center in Charleston, and the Memorial Sloan Kettering Cancer Center in New York City.
Synopsis: Six hundred fifty ICU patients were randomized to receive care either in rooms with copper surfacing on commonly handled patient care objects or in traditional rooms. Patients were screened for methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant enterococci (VRE) on admission. The proportion of patients that developed either an HAI and/or MRSA or VRE colonization was significantly lower among patients in rooms with the copper-surfaced items (0.071 vs. 0.128; P=0.02). The rate of HAIs alone was also lower in the rooms with the copper (0.034 vs. 0.081; P=0.013).
A potential limitation to this study is that the rooms with copper items appeared different than traditional rooms, and therefore might have changed the behavior of health-care workers. Further, it is unclear how much copper surfacing would be necessary on general wards, where patients are more mobile. Still, HAIs are associated with longer lengths of stay and higher 30-day readmission rates, so these encouraging results warrant additional investigation into antimicrobial copper-alloy surfaces.
Bottom line: Copper-surfaced objects reduce HAI rates in ICU patients.
Citation: Salgado CD, Sepkowitz, KA, John JF, et al. Copper surfaces reduce the rate of healthcare-acquired infections in the intensive care unit. Infect Control Hosp Epidemiol. 2013;34(5):479-486.
Glucocorticoid Therapy for Five Days Not Inferior to 14 Days for COPD Exacerbation
Clinical question: Do short-course glucocorticoids work as well as conventional long courses for COPD exacerbation?
Background: International guidelines advocate a seven- to 14-day treatment course with glucocorticoids for COPD exacerbation, but the optimal duration of treatment is not known, and there are potential risks associated with glucocorticoid exposure.
Study design: Randomized, noninferiority, multicenter trial.
Setting: Five Swiss teaching hospitals.
Synopsis: Three hundred fourteen patients presenting to the ED with acute COPD exacerbation and without a history of asthma were randomized to receive treatment with 40 mg prednisone daily for either five or 14 days in a placebo-controlled, double-blinded fashion. There was no significant difference in the primary endpoint of re-exacerbation within six months. Patients in the five-day glucocorticoid group compared with the 14-day group were exposed to significantly less glucocorticoid.
Bottom line: Treatment for five days with glucocorticoids was not inferior to 14 days for acute COPD exacerbations with regard to re-exacerbations within six months and resulted in less glucocorticoid exposure overall.
Citation: Leuppi JF, Schuetz P, Bingisser R, et al. Short-term vs. conventional glucocorticoid therapy in acute exacerbations of chronic obstructive pulmonary disease: the REDUCE Randomized Clinical Trial. JAMA. 2013;390(21):2223-2231.
Patient Preference for Participation in Medical Decision-Making May Be Associated with Increased Resource Utilization
Clinical question: Do patient preferences for participation in medical decision-making affect health-care utilization?
Background: Patient participation in medical decision-making has been associated with improved patient satisfaction and health outcomes. There is little evidence to support theories that patient preferences might decrease or increase health-care utilization.
Study design: Survey study in academic research setting.
Setting: University of Chicago Medical Center.
Synopsis: More than 21,700 patients admitted to a general internal-medicine service completed a survey that included questions regarding preferences about receiving medical information and participation in medical decision-making. Survey data were linked with administrative data, including length of stay and total hospitalization costs.
Most patients (96.3%) expressed interest in receiving information about their illness and treatment options, but the majority of patients (71.1%) also expressed a preference to leave medical decision-making to their physician. Patients who preferred to participate in medical decision-making had significantly longer hospital LOS and higher total hospitalization cost.
Bottom line: Participation in medical decision-making significantly increased LOS and total costs.
Citation: Tak HJ, Ruhnke GW, Meltzer DO. Association of patient preferences for participation in decision making with length of stay and costs among hospitalized patients. JAMA Intern Med. 2013;173(13):1195-1205. doi: 10.1001/jamainternmed.2013.6048.
Early Parenteral Nutrition in Critically Ill Adults Does Not Significantly Affect Mortality or Infection Rates
Clinical question: Does providing early parenteral nutrition to critically ill adults with short-term relative contraindications to early enteral nutrition affect outcomes?
Background: The appropriate use of parenteral nutrition in critically ill adults is controversial. A systematic review found that critically ill patients randomized to receive early parenteral nutrition had significantly lower mortality but increased infection rates compared with standard care. A large-scale randomized trial was necessary to confirm the results.
Study design: Multicenter, randomized, single-blinded, controlled trial.
Setting: ICUs in 31 tertiary-care and community hospitals in Australia and New Zealand.
Synopsis: Researchers randomized 1,372 critically ill adults with relative contraindications to early enteral nutrition upon admission to the ICU to receive early parenteral nutrition or standard care. Early parenteral nutrition was started an average of 44 minutes after randomization. Clinicians defined standard care, with most patients remaining unfed for 2.8 days after randomization. Results were analyzed by intention-to-treat analysis, and loss to follow-up was 1%.
There was no significant difference in the primary outcome of 60-day mortality. Early parenteral nutrition patients received significantly fewer days of invasive ventilation, but did not have shorter ICU or hospital stays. Early parenteral nutrition patients experienced significantly less muscle-wasting and fat loss. There was no significant difference in new infection rates.
Bottom line: Early parenteral nutrition in critically ill adults resulted in significantly fewer days of invasive mechanical ventilation but did not cause a significant difference in length of stay, infection rates, or 60-day mortality.
Citation: Doig GS, Simpson F, Sweetman EA, et al. Early parenteral nutrition in critically ill patients with short-term relative contraindications to early enteral nutrition. JAMA. 2013;309(20): 2130-2138.
Aggressive Fluid and Sodium Restriction in Acute Decompensated Heart Failure Did Not Improve Outcomes
Clinical question: Does aggressive fluid and sodium restriction in acute decompensated heart failure (ADHF) result in increased weight loss, improved clinical stability, or decreased 30-day readmission rate?
Background: Fluid and sodium restriction are standard nonpharmacologic measures used in the management of ADHF in hospitalized patients, despite an absence of data to support their efficacy.
Study design: Randomized, controlled clinical trial with blinded outcome assessments.
Setting: A public teaching hospital in Brazil.
Synopsis: Seventy-five patients hospitalized with ADHF were randomized to receive aggressive fluid (800 mL/day) and sodium restriction (800 mg/day) or liberal intake (at least 2.5 L/day fluid, 3 to 5 g/day sodium). There were no significant between-group differences in diuretic administration. The primary outcomes of weight loss and clinical stability at three days were not significantly different between the groups. The heart-failure-specific readmission rate at 30 days was not significantly different between the groups. The aggressive restriction group had significantly worse thirst.
The study is limited by the small fraction of patients enrolled (9.2% of 813 screened) and homogenous population. Additional confirmatory trials likely are needed to change the standard of care, but this study demonstrated that aggressive fluid and sodium restriction does not benefit hospitalized patients with ADHF.
Bottom line: Aggressive fluid and sodium restriction in hospitalized patients with ADHF does not result in improved short-term weight loss, clinical stability, or decreased 30-day readmission rate, but it does cause significantly worse thirst.
Citation: Aliti GB, Rabelo ER, Clausell N, et al. Aggressive fluid and sodium restriction in acute decompensated heart failure. JAMA Intern Med. 2013;173(12):1058-1064.
Lower Rate of Pacemaker, Defibrillator Device-Pocket Hematoma without Anticoagulation Interruption
Clinical question: Is it safer to place a pacemaker or implantable cardioverter-defibrillator (ICD) while on therapeutic warfarin versus bridging with heparin/low-molecular-weight heparin (LMWH)?
Background: Current guidelines recommend bridging with heparin or LMWH for patients at high risk for thromboembolic events around the time of pacemaker or ICD placement, but it is associated with significant risk of device-pocket hematoma. Some centers place pacemakers and ICDs without interruption of warfarin. However, there are limited data to support the safety of this approach.
Study design: Multicenter, single-blinded, randomized, controlled trial.
Setting: Seventeen centers in Canada and one center in Brazil.
Synopsis: Patients with a predicted annual risk of 5% of thromboembolism were randomized to continue anticoagulation with warfarin (median INR 2.3) or to bridge therapy with heparin or LMWH; they then evaluated the incidence of clinically significant hematoma requiring prolonged hospitalization, interruption of anticoagulation therapy, or further surgical intervention. After reviewing the data on 668 patients, the Data and Safety Monitoring Board recommended termination of the study given a significantly lower rate of device-pocket hematoma in the warfarin group (3.5%) compared with the bridge group (16%) with RR 0.19 (95% CI 0.10-0.36, P<0.001). Otherwise, major surgical and thromboembolic complications were rare and not significantly different in both groups.
Bottom line: Continued warfarin therapy was associated with significantly reduced incidence of device-pocket hematoma compared with bridge with heparin or LMWH.
Citation: Birnie DH, Healey JS, Wells GA, et al. Pacemaker or defibrillator surgery without interruption of anticoagulation. N Engl J Med. 2013;368(22):2084-2093.
Prophylactic Penicillin Decreased Risk of Recurrent Leg Cellulitis
Clinical question: Does prophylactic, low-dose penicillin prevent recurrent cellulitis in patients with a history of two or more episodes of cellulitis?
Background: Some guidelines recommend prophylactic antibiotics for recurrent leg cellulitis, but there is no large randomized trial to support this practice, and clinical opinion is mixed.
Study design: Double-blinded, randomized, controlled trial.
Setting: Twenty-eight hospitals in the United Kingdom and Ireland.
Synopsis: Researchers randomized 274 patients with recurrent episodes of leg cellulitis (at least two episodes within the previous three years) to low-dose penicillin (250 mg) or placebo for 12 months and followed them for more than three years. During the prophylactic period, the penicillin group had a 45% reduction in the risk of a repeat cellulitis as compared to placebo (22% vs. 37%), equivalent to a number needed to treat to prevent a first recurrent cellulitis of five. The number of repeat episodes of cellulitis was lower overall in penicillin compared with the placebo group (119 vs. 164, P=0.02), although no significant difference was noted during the three-year follow-up period.
Factors associated with prophylaxis failure included three or more previous episodes of cellulitis, body mass index of 33 kg/m² or higher, and the presence of edema. No significant difference in adverse events was noted between the groups. Complete follow-up data was not available for participants during the follow-up period. Further study is needed to assess the long-term adverse effects and the duration of prophylaxis needed.
Bottom line: Prophylactic penicillin was effective in preventing recurrent leg cellulitis without increasing adverse effects, but its protective effect gradually declined once discontinued.
Citation: Thomas KS, Crook AM, Nunn AJ, et al. Penicillin to prevent recurrent leg cellulitis. N Engl J Med. 2013;368(18):1695-1703.
Universal ICU Decolonization Reduced Rates of MRSA Clinical Isolates and Bloodstream Infection
Clinical question: What is the most effective decolonization strategy for reducing methicillin-resistant Staphylococcus aureus (MRSA) and other pathogens in ICUs?
Background: Studies have shown that daily chlorhexidine bathing of all patients in ICUs reduced MRSA acquisition and bloodstream infection from all pathogens. However, this universal strategy has not been compared to MRSA screening and contact precautions alone, or to targeted decolonization of MRSA carriers.
Study design: Cluster-randomized comparative-effectiveness trial.
Setting: Adult ICUs in 43 Hospital Corporation of America (HCA) hospitals in 16 states.
Synopsis: All adult ICUs in a given hospital were randomized to one of three infection prevention strategies: Group 1 continued MRSA screening and isolation; Group 2 performed screening, isolation, and decolonization of MRSA carriers; and Group 3 implemented universal decolonization with intranasal mupirocin and daily bathing with chlorhexidine-impregnated cloths but no screening.
Forty-three hospitals, including 74 ICUs and 74,256 patients, underwent randomization. Significant reductions in the primary outcome of ICU-attributable MRSA clinical isolates (excluding MRSA screening tests) and the secondary outcome of bloodstream infection due to any pathogen were demonstrated across the three groups. One bloodstream infection was prevented for every 54 patients who underwent decolonization. Formal cost-effectiveness analysis was not performed.
Bottom line: In the ICU, universal decolonization was more effective than screening and isolation or targeted decolonization in the reduction of clinical MRSA isolates and bloodstream infection due to any pathogen, although monitoring for emerging resistance is necessary.
Citation: Huang SS, Septimus E, Kleinman K, et al. Targeted versus universal decolonization to prevent ICU infection. N Engl J Med. 2013;368(24):2255-2265.
Intensive Blood-Pressure Lowering in Intracerebral Hemorrhage Did Not Reduce Death or Severe Disability
Clinical question: What is the efficacy and safety of early intensive blood-pressure lowering in patients with acute intracerebral hemorrhage?
Background: After intracerebral hemorrhage, blood pressure often becomes elevated and is a predictor of outcome. It is not known whether rapid lowering of blood pressure would improve outcome.
Study design: International, multicenter, prospective, randomized, open-treatment, blinded end-point trial.
Setting: One hundred forty-four hospitals in 21 countries.
Synopsis: Researchers randomly assigned 2,839 patients with intracerebral hemorrhage in the previous six hours to intensive blood-pressure lowering with target systolic blood pressure of <140 mmHg within one hour, or guideline-recommended treatment with target systolic blood pressure of <180 mmHg. The mean systolic blood pressure achieved was 150 mmHg in the intensive-treatment group and 164 mmHg in the standard-treatment group.
There was no significant difference between the two groups in the primary outcome of death or major disability. A pre-specified ordinal analysis of modified Rankin score (score of 0 indicates no symptoms; a score of 5 indicates severe disability) did show significantly lower modified Rankin scores with intensive treatment. There was no difference between the two groups in the rate of serious adverse events.
Bottom line: Early intensive blood-pressure lowering in patients with acute intracerebral hemorrhage did not reduce death or major disability, although there may be improved functional outcomes with intensive blood-pressure lowering.
Citation: Anderson CS, Heeley E, Huang Y, et al. Rapid blood-pressure lowering in patients with acute intracerebral hemorrhage. N Engl J Med. 2013;368(25):2355-2365.
In This Edition
Literature At A Glance
A guide to this month’s studies
- Perioperative SSRI use associated with adverse surgical outcomes
- Copper-surfaced rooms reduce health-care-acquired infections
- Glucocorticoid therapy for five days not inferior to 14 days for COPD exacerbation
- Patient preference for participation in medical decision-making may be associated with increased resource utilization
- Early parenteral nutrition in critically ill adults does not significantly affect mortality or infection rates
- Aggressive fluid and sodium restriction in acute decompensated heart failure did not improve outcomes
- Lower rate of pacemaker, defibrillator device-pocket hematoma without anticoagulation interruption
- Prophylactic penicillin decreased risk of recurrent leg cellulitis
- Universal ICU decolonization reduced rates of mrsa clinical isolates and bloodstream infection
- Intensive blood-pressure lowering in intracerebral hemorrhage did not reduce death or severe disability
Perioperative SSRI Use Associated with Adverse Surgical Outcomes
Clinical question: Does selective serotonin reuptake inhibitor (SSRI) use during hospitalization for surgery increase the risk of adverse perioperative outcomes?
Background: SSRIs commonly are prescribed but are associated with a small but higher risk for hemorrhage, arrhythmia, and sudden death. Single-site studies have described an association between SSRIs and adverse perioperative outcomes, but larger studies utilizing a broad range of surgical cases are lacking.
Study design: Retrospective cohort study.
Setting: Three hundred hospitals concentrated in the Southern U.S.
Synopsis: Using the “Perspective” database, this study examined 530,416 patients age >18 years undergoing major elective surgery, 72,540 (13.7%) of whom received an SSRI. Regression analysis showed patients receiving an SSRI had higher odds of mortality (OR 1.2, 95% CI [1.07-1.36]), higher odds of 30-day readmission (OR 1.22 [1.18-1.26]), and higher odds for bleeding (1.09 [1.04-1.15]). When the analysis was restricted to only patients with a diagnosis of depression, a higher risk of bleeding and readmission persisted.
This study reaffirms an association but does not establish a causal relationship between SSRI use and adverse perioperative outcomes. SSRI use may be a surrogate for other factors, including more severe mood disorders, poorer functional status, or chronic pain. Additionally, no information has been provided as to optimal duration of withholding SSRIs preoperatively. As such, it may be premature for hospitalists involved in perioperative care to modify recommendations based on this study.
Bottom line: Perioperative SSRI use is associated with an increased risk of bleeding and 30-day readmission.
Citation: Auerbach AD, Vittinghoff E, Maselli J, et al. Perioperative use of selective serotonin reuptake inhibitors and risks for adverse outcomes of surgery. JAMA Intern Med. 2013;173(12):1075-1081.
Copper-Surfaced Rooms Reduce Health-Care-Acquired Infections
Clinical question: Can copper alloy surfaces in ICU rooms lower rates of health-care-acquired infections (HAIs)?
Background: Environmental contamination is a potential source of HAIs. Copper has intrinsic broad-spectrum antimicrobial properties. This study tests the efficacy copper-surfaced items in hospital rooms have in preventing HAIs.
Study design: Randomized controlled trial.
Setting: Medical ICUs at Medical University of South Carolina and Ralph H. Johnson Veterans Affairs Medical Center in Charleston, and the Memorial Sloan Kettering Cancer Center in New York City.
Synopsis: Six hundred fifty ICU patients were randomized to receive care either in rooms with copper surfacing on commonly handled patient care objects or in traditional rooms. Patients were screened for methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant enterococci (VRE) on admission. The proportion of patients that developed either an HAI and/or MRSA or VRE colonization was significantly lower among patients in rooms with the copper-surfaced items (0.071 vs. 0.128; P=0.02). The rate of HAIs alone was also lower in the rooms with the copper (0.034 vs. 0.081; P=0.013).
A potential limitation to this study is that the rooms with copper items appeared different than traditional rooms, and therefore might have changed the behavior of health-care workers. Further, it is unclear how much copper surfacing would be necessary on general wards, where patients are more mobile. Still, HAIs are associated with longer lengths of stay and higher 30-day readmission rates, so these encouraging results warrant additional investigation into antimicrobial copper-alloy surfaces.
Bottom line: Copper-surfaced objects reduce HAI rates in ICU patients.
Citation: Salgado CD, Sepkowitz, KA, John JF, et al. Copper surfaces reduce the rate of healthcare-acquired infections in the intensive care unit. Infect Control Hosp Epidemiol. 2013;34(5):479-486.
Glucocorticoid Therapy for Five Days Not Inferior to 14 Days for COPD Exacerbation
Clinical question: Do short-course glucocorticoids work as well as conventional long courses for COPD exacerbation?
Background: International guidelines advocate a seven- to 14-day treatment course with glucocorticoids for COPD exacerbation, but the optimal duration of treatment is not known, and there are potential risks associated with glucocorticoid exposure.
Study design: Randomized, noninferiority, multicenter trial.
Setting: Five Swiss teaching hospitals.
Synopsis: Three hundred fourteen patients presenting to the ED with acute COPD exacerbation and without a history of asthma were randomized to receive treatment with 40 mg prednisone daily for either five or 14 days in a placebo-controlled, double-blinded fashion. There was no significant difference in the primary endpoint of re-exacerbation within six months. Patients in the five-day glucocorticoid group compared with the 14-day group were exposed to significantly less glucocorticoid.
Bottom line: Treatment for five days with glucocorticoids was not inferior to 14 days for acute COPD exacerbations with regard to re-exacerbations within six months and resulted in less glucocorticoid exposure overall.
Citation: Leuppi JF, Schuetz P, Bingisser R, et al. Short-term vs. conventional glucocorticoid therapy in acute exacerbations of chronic obstructive pulmonary disease: the REDUCE Randomized Clinical Trial. JAMA. 2013;390(21):2223-2231.
Patient Preference for Participation in Medical Decision-Making May Be Associated with Increased Resource Utilization
Clinical question: Do patient preferences for participation in medical decision-making affect health-care utilization?
Background: Patient participation in medical decision-making has been associated with improved patient satisfaction and health outcomes. There is little evidence to support theories that patient preferences might decrease or increase health-care utilization.
Study design: Survey study in academic research setting.
Setting: University of Chicago Medical Center.
Synopsis: More than 21,700 patients admitted to a general internal-medicine service completed a survey that included questions regarding preferences about receiving medical information and participation in medical decision-making. Survey data were linked with administrative data, including length of stay and total hospitalization costs.
Most patients (96.3%) expressed interest in receiving information about their illness and treatment options, but the majority of patients (71.1%) also expressed a preference to leave medical decision-making to their physician. Patients who preferred to participate in medical decision-making had significantly longer hospital LOS and higher total hospitalization cost.
Bottom line: Participation in medical decision-making significantly increased LOS and total costs.
Citation: Tak HJ, Ruhnke GW, Meltzer DO. Association of patient preferences for participation in decision making with length of stay and costs among hospitalized patients. JAMA Intern Med. 2013;173(13):1195-1205. doi: 10.1001/jamainternmed.2013.6048.
Early Parenteral Nutrition in Critically Ill Adults Does Not Significantly Affect Mortality or Infection Rates
Clinical question: Does providing early parenteral nutrition to critically ill adults with short-term relative contraindications to early enteral nutrition affect outcomes?
Background: The appropriate use of parenteral nutrition in critically ill adults is controversial. A systematic review found that critically ill patients randomized to receive early parenteral nutrition had significantly lower mortality but increased infection rates compared with standard care. A large-scale randomized trial was necessary to confirm the results.
Study design: Multicenter, randomized, single-blinded, controlled trial.
Setting: ICUs in 31 tertiary-care and community hospitals in Australia and New Zealand.
Synopsis: Researchers randomized 1,372 critically ill adults with relative contraindications to early enteral nutrition upon admission to the ICU to receive early parenteral nutrition or standard care. Early parenteral nutrition was started an average of 44 minutes after randomization. Clinicians defined standard care, with most patients remaining unfed for 2.8 days after randomization. Results were analyzed by intention-to-treat analysis, and loss to follow-up was 1%.
There was no significant difference in the primary outcome of 60-day mortality. Early parenteral nutrition patients received significantly fewer days of invasive ventilation, but did not have shorter ICU or hospital stays. Early parenteral nutrition patients experienced significantly less muscle-wasting and fat loss. There was no significant difference in new infection rates.
Bottom line: Early parenteral nutrition in critically ill adults resulted in significantly fewer days of invasive mechanical ventilation but did not cause a significant difference in length of stay, infection rates, or 60-day mortality.
Citation: Doig GS, Simpson F, Sweetman EA, et al. Early parenteral nutrition in critically ill patients with short-term relative contraindications to early enteral nutrition. JAMA. 2013;309(20): 2130-2138.
Aggressive Fluid and Sodium Restriction in Acute Decompensated Heart Failure Did Not Improve Outcomes
Clinical question: Does aggressive fluid and sodium restriction in acute decompensated heart failure (ADHF) result in increased weight loss, improved clinical stability, or decreased 30-day readmission rate?
Background: Fluid and sodium restriction are standard nonpharmacologic measures used in the management of ADHF in hospitalized patients, despite an absence of data to support their efficacy.
Study design: Randomized, controlled clinical trial with blinded outcome assessments.
Setting: A public teaching hospital in Brazil.
Synopsis: Seventy-five patients hospitalized with ADHF were randomized to receive aggressive fluid (800 mL/day) and sodium restriction (800 mg/day) or liberal intake (at least 2.5 L/day fluid, 3 to 5 g/day sodium). There were no significant between-group differences in diuretic administration. The primary outcomes of weight loss and clinical stability at three days were not significantly different between the groups. The heart-failure-specific readmission rate at 30 days was not significantly different between the groups. The aggressive restriction group had significantly worse thirst.
The study is limited by the small fraction of patients enrolled (9.2% of 813 screened) and homogenous population. Additional confirmatory trials likely are needed to change the standard of care, but this study demonstrated that aggressive fluid and sodium restriction does not benefit hospitalized patients with ADHF.
Bottom line: Aggressive fluid and sodium restriction in hospitalized patients with ADHF does not result in improved short-term weight loss, clinical stability, or decreased 30-day readmission rate, but it does cause significantly worse thirst.
Citation: Aliti GB, Rabelo ER, Clausell N, et al. Aggressive fluid and sodium restriction in acute decompensated heart failure. JAMA Intern Med. 2013;173(12):1058-1064.
Lower Rate of Pacemaker, Defibrillator Device-Pocket Hematoma without Anticoagulation Interruption
Clinical question: Is it safer to place a pacemaker or implantable cardioverter-defibrillator (ICD) while on therapeutic warfarin versus bridging with heparin/low-molecular-weight heparin (LMWH)?
Background: Current guidelines recommend bridging with heparin or LMWH for patients at high risk for thromboembolic events around the time of pacemaker or ICD placement, but it is associated with significant risk of device-pocket hematoma. Some centers place pacemakers and ICDs without interruption of warfarin. However, there are limited data to support the safety of this approach.
Study design: Multicenter, single-blinded, randomized, controlled trial.
Setting: Seventeen centers in Canada and one center in Brazil.
Synopsis: Patients with a predicted annual risk of 5% of thromboembolism were randomized to continue anticoagulation with warfarin (median INR 2.3) or to bridge therapy with heparin or LMWH; they then evaluated the incidence of clinically significant hematoma requiring prolonged hospitalization, interruption of anticoagulation therapy, or further surgical intervention. After reviewing the data on 668 patients, the Data and Safety Monitoring Board recommended termination of the study given a significantly lower rate of device-pocket hematoma in the warfarin group (3.5%) compared with the bridge group (16%) with RR 0.19 (95% CI 0.10-0.36, P<0.001). Otherwise, major surgical and thromboembolic complications were rare and not significantly different in both groups.
Bottom line: Continued warfarin therapy was associated with significantly reduced incidence of device-pocket hematoma compared with bridge with heparin or LMWH.
Citation: Birnie DH, Healey JS, Wells GA, et al. Pacemaker or defibrillator surgery without interruption of anticoagulation. N Engl J Med. 2013;368(22):2084-2093.
Prophylactic Penicillin Decreased Risk of Recurrent Leg Cellulitis
Clinical question: Does prophylactic, low-dose penicillin prevent recurrent cellulitis in patients with a history of two or more episodes of cellulitis?
Background: Some guidelines recommend prophylactic antibiotics for recurrent leg cellulitis, but there is no large randomized trial to support this practice, and clinical opinion is mixed.
Study design: Double-blinded, randomized, controlled trial.
Setting: Twenty-eight hospitals in the United Kingdom and Ireland.
Synopsis: Researchers randomized 274 patients with recurrent episodes of leg cellulitis (at least two episodes within the previous three years) to low-dose penicillin (250 mg) or placebo for 12 months and followed them for more than three years. During the prophylactic period, the penicillin group had a 45% reduction in the risk of a repeat cellulitis as compared to placebo (22% vs. 37%), equivalent to a number needed to treat to prevent a first recurrent cellulitis of five. The number of repeat episodes of cellulitis was lower overall in penicillin compared with the placebo group (119 vs. 164, P=0.02), although no significant difference was noted during the three-year follow-up period.
Factors associated with prophylaxis failure included three or more previous episodes of cellulitis, body mass index of 33 kg/m² or higher, and the presence of edema. No significant difference in adverse events was noted between the groups. Complete follow-up data was not available for participants during the follow-up period. Further study is needed to assess the long-term adverse effects and the duration of prophylaxis needed.
Bottom line: Prophylactic penicillin was effective in preventing recurrent leg cellulitis without increasing adverse effects, but its protective effect gradually declined once discontinued.
Citation: Thomas KS, Crook AM, Nunn AJ, et al. Penicillin to prevent recurrent leg cellulitis. N Engl J Med. 2013;368(18):1695-1703.
Universal ICU Decolonization Reduced Rates of MRSA Clinical Isolates and Bloodstream Infection
Clinical question: What is the most effective decolonization strategy for reducing methicillin-resistant Staphylococcus aureus (MRSA) and other pathogens in ICUs?
Background: Studies have shown that daily chlorhexidine bathing of all patients in ICUs reduced MRSA acquisition and bloodstream infection from all pathogens. However, this universal strategy has not been compared to MRSA screening and contact precautions alone, or to targeted decolonization of MRSA carriers.
Study design: Cluster-randomized comparative-effectiveness trial.
Setting: Adult ICUs in 43 Hospital Corporation of America (HCA) hospitals in 16 states.
Synopsis: All adult ICUs in a given hospital were randomized to one of three infection prevention strategies: Group 1 continued MRSA screening and isolation; Group 2 performed screening, isolation, and decolonization of MRSA carriers; and Group 3 implemented universal decolonization with intranasal mupirocin and daily bathing with chlorhexidine-impregnated cloths but no screening.
Forty-three hospitals, including 74 ICUs and 74,256 patients, underwent randomization. Significant reductions in the primary outcome of ICU-attributable MRSA clinical isolates (excluding MRSA screening tests) and the secondary outcome of bloodstream infection due to any pathogen were demonstrated across the three groups. One bloodstream infection was prevented for every 54 patients who underwent decolonization. Formal cost-effectiveness analysis was not performed.
Bottom line: In the ICU, universal decolonization was more effective than screening and isolation or targeted decolonization in the reduction of clinical MRSA isolates and bloodstream infection due to any pathogen, although monitoring for emerging resistance is necessary.
Citation: Huang SS, Septimus E, Kleinman K, et al. Targeted versus universal decolonization to prevent ICU infection. N Engl J Med. 2013;368(24):2255-2265.
Intensive Blood-Pressure Lowering in Intracerebral Hemorrhage Did Not Reduce Death or Severe Disability
Clinical question: What is the efficacy and safety of early intensive blood-pressure lowering in patients with acute intracerebral hemorrhage?
Background: After intracerebral hemorrhage, blood pressure often becomes elevated and is a predictor of outcome. It is not known whether rapid lowering of blood pressure would improve outcome.
Study design: International, multicenter, prospective, randomized, open-treatment, blinded end-point trial.
Setting: One hundred forty-four hospitals in 21 countries.
Synopsis: Researchers randomly assigned 2,839 patients with intracerebral hemorrhage in the previous six hours to intensive blood-pressure lowering with target systolic blood pressure of <140 mmHg within one hour, or guideline-recommended treatment with target systolic blood pressure of <180 mmHg. The mean systolic blood pressure achieved was 150 mmHg in the intensive-treatment group and 164 mmHg in the standard-treatment group.
There was no significant difference between the two groups in the primary outcome of death or major disability. A pre-specified ordinal analysis of modified Rankin score (score of 0 indicates no symptoms; a score of 5 indicates severe disability) did show significantly lower modified Rankin scores with intensive treatment. There was no difference between the two groups in the rate of serious adverse events.
Bottom line: Early intensive blood-pressure lowering in patients with acute intracerebral hemorrhage did not reduce death or major disability, although there may be improved functional outcomes with intensive blood-pressure lowering.
Citation: Anderson CS, Heeley E, Huang Y, et al. Rapid blood-pressure lowering in patients with acute intracerebral hemorrhage. N Engl J Med. 2013;368(25):2355-2365.
In This Edition
Literature At A Glance
A guide to this month’s studies
- Perioperative SSRI use associated with adverse surgical outcomes
- Copper-surfaced rooms reduce health-care-acquired infections
- Glucocorticoid therapy for five days not inferior to 14 days for COPD exacerbation
- Patient preference for participation in medical decision-making may be associated with increased resource utilization
- Early parenteral nutrition in critically ill adults does not significantly affect mortality or infection rates
- Aggressive fluid and sodium restriction in acute decompensated heart failure did not improve outcomes
- Lower rate of pacemaker, defibrillator device-pocket hematoma without anticoagulation interruption
- Prophylactic penicillin decreased risk of recurrent leg cellulitis
- Universal ICU decolonization reduced rates of mrsa clinical isolates and bloodstream infection
- Intensive blood-pressure lowering in intracerebral hemorrhage did not reduce death or severe disability
Perioperative SSRI Use Associated with Adverse Surgical Outcomes
Clinical question: Does selective serotonin reuptake inhibitor (SSRI) use during hospitalization for surgery increase the risk of adverse perioperative outcomes?
Background: SSRIs commonly are prescribed but are associated with a small but higher risk for hemorrhage, arrhythmia, and sudden death. Single-site studies have described an association between SSRIs and adverse perioperative outcomes, but larger studies utilizing a broad range of surgical cases are lacking.
Study design: Retrospective cohort study.
Setting: Three hundred hospitals concentrated in the Southern U.S.
Synopsis: Using the “Perspective” database, this study examined 530,416 patients age >18 years undergoing major elective surgery, 72,540 (13.7%) of whom received an SSRI. Regression analysis showed patients receiving an SSRI had higher odds of mortality (OR 1.2, 95% CI [1.07-1.36]), higher odds of 30-day readmission (OR 1.22 [1.18-1.26]), and higher odds for bleeding (1.09 [1.04-1.15]). When the analysis was restricted to only patients with a diagnosis of depression, a higher risk of bleeding and readmission persisted.
This study reaffirms an association but does not establish a causal relationship between SSRI use and adverse perioperative outcomes. SSRI use may be a surrogate for other factors, including more severe mood disorders, poorer functional status, or chronic pain. Additionally, no information has been provided as to optimal duration of withholding SSRIs preoperatively. As such, it may be premature for hospitalists involved in perioperative care to modify recommendations based on this study.
Bottom line: Perioperative SSRI use is associated with an increased risk of bleeding and 30-day readmission.
Citation: Auerbach AD, Vittinghoff E, Maselli J, et al. Perioperative use of selective serotonin reuptake inhibitors and risks for adverse outcomes of surgery. JAMA Intern Med. 2013;173(12):1075-1081.
Copper-Surfaced Rooms Reduce Health-Care-Acquired Infections
Clinical question: Can copper alloy surfaces in ICU rooms lower rates of health-care-acquired infections (HAIs)?
Background: Environmental contamination is a potential source of HAIs. Copper has intrinsic broad-spectrum antimicrobial properties. This study tests the efficacy copper-surfaced items in hospital rooms have in preventing HAIs.
Study design: Randomized controlled trial.
Setting: Medical ICUs at Medical University of South Carolina and Ralph H. Johnson Veterans Affairs Medical Center in Charleston, and the Memorial Sloan Kettering Cancer Center in New York City.
Synopsis: Six hundred fifty ICU patients were randomized to receive care either in rooms with copper surfacing on commonly handled patient care objects or in traditional rooms. Patients were screened for methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant enterococci (VRE) on admission. The proportion of patients that developed either an HAI and/or MRSA or VRE colonization was significantly lower among patients in rooms with the copper-surfaced items (0.071 vs. 0.128; P=0.02). The rate of HAIs alone was also lower in the rooms with the copper (0.034 vs. 0.081; P=0.013).
A potential limitation to this study is that the rooms with copper items appeared different than traditional rooms, and therefore might have changed the behavior of health-care workers. Further, it is unclear how much copper surfacing would be necessary on general wards, where patients are more mobile. Still, HAIs are associated with longer lengths of stay and higher 30-day readmission rates, so these encouraging results warrant additional investigation into antimicrobial copper-alloy surfaces.
Bottom line: Copper-surfaced objects reduce HAI rates in ICU patients.
Citation: Salgado CD, Sepkowitz, KA, John JF, et al. Copper surfaces reduce the rate of healthcare-acquired infections in the intensive care unit. Infect Control Hosp Epidemiol. 2013;34(5):479-486.
Glucocorticoid Therapy for Five Days Not Inferior to 14 Days for COPD Exacerbation
Clinical question: Do short-course glucocorticoids work as well as conventional long courses for COPD exacerbation?
Background: International guidelines advocate a seven- to 14-day treatment course with glucocorticoids for COPD exacerbation, but the optimal duration of treatment is not known, and there are potential risks associated with glucocorticoid exposure.
Study design: Randomized, noninferiority, multicenter trial.
Setting: Five Swiss teaching hospitals.
Synopsis: Three hundred fourteen patients presenting to the ED with acute COPD exacerbation and without a history of asthma were randomized to receive treatment with 40 mg prednisone daily for either five or 14 days in a placebo-controlled, double-blinded fashion. There was no significant difference in the primary endpoint of re-exacerbation within six months. Patients in the five-day glucocorticoid group compared with the 14-day group were exposed to significantly less glucocorticoid.
Bottom line: Treatment for five days with glucocorticoids was not inferior to 14 days for acute COPD exacerbations with regard to re-exacerbations within six months and resulted in less glucocorticoid exposure overall.
Citation: Leuppi JF, Schuetz P, Bingisser R, et al. Short-term vs. conventional glucocorticoid therapy in acute exacerbations of chronic obstructive pulmonary disease: the REDUCE Randomized Clinical Trial. JAMA. 2013;390(21):2223-2231.
Patient Preference for Participation in Medical Decision-Making May Be Associated with Increased Resource Utilization
Clinical question: Do patient preferences for participation in medical decision-making affect health-care utilization?
Background: Patient participation in medical decision-making has been associated with improved patient satisfaction and health outcomes. There is little evidence to support theories that patient preferences might decrease or increase health-care utilization.
Study design: Survey study in academic research setting.
Setting: University of Chicago Medical Center.
Synopsis: More than 21,700 patients admitted to a general internal-medicine service completed a survey that included questions regarding preferences about receiving medical information and participation in medical decision-making. Survey data were linked with administrative data, including length of stay and total hospitalization costs.
Most patients (96.3%) expressed interest in receiving information about their illness and treatment options, but the majority of patients (71.1%) also expressed a preference to leave medical decision-making to their physician. Patients who preferred to participate in medical decision-making had significantly longer hospital LOS and higher total hospitalization cost.
Bottom line: Participation in medical decision-making significantly increased LOS and total costs.
Citation: Tak HJ, Ruhnke GW, Meltzer DO. Association of patient preferences for participation in decision making with length of stay and costs among hospitalized patients. JAMA Intern Med. 2013;173(13):1195-1205. doi: 10.1001/jamainternmed.2013.6048.
Early Parenteral Nutrition in Critically Ill Adults Does Not Significantly Affect Mortality or Infection Rates
Clinical question: Does providing early parenteral nutrition to critically ill adults with short-term relative contraindications to early enteral nutrition affect outcomes?
Background: The appropriate use of parenteral nutrition in critically ill adults is controversial. A systematic review found that critically ill patients randomized to receive early parenteral nutrition had significantly lower mortality but increased infection rates compared with standard care. A large-scale randomized trial was necessary to confirm the results.
Study design: Multicenter, randomized, single-blinded, controlled trial.
Setting: ICUs in 31 tertiary-care and community hospitals in Australia and New Zealand.
Synopsis: Researchers randomized 1,372 critically ill adults with relative contraindications to early enteral nutrition upon admission to the ICU to receive early parenteral nutrition or standard care. Early parenteral nutrition was started an average of 44 minutes after randomization. Clinicians defined standard care, with most patients remaining unfed for 2.8 days after randomization. Results were analyzed by intention-to-treat analysis, and loss to follow-up was 1%.
There was no significant difference in the primary outcome of 60-day mortality. Early parenteral nutrition patients received significantly fewer days of invasive ventilation, but did not have shorter ICU or hospital stays. Early parenteral nutrition patients experienced significantly less muscle-wasting and fat loss. There was no significant difference in new infection rates.
Bottom line: Early parenteral nutrition in critically ill adults resulted in significantly fewer days of invasive mechanical ventilation but did not cause a significant difference in length of stay, infection rates, or 60-day mortality.
Citation: Doig GS, Simpson F, Sweetman EA, et al. Early parenteral nutrition in critically ill patients with short-term relative contraindications to early enteral nutrition. JAMA. 2013;309(20): 2130-2138.
Aggressive Fluid and Sodium Restriction in Acute Decompensated Heart Failure Did Not Improve Outcomes
Clinical question: Does aggressive fluid and sodium restriction in acute decompensated heart failure (ADHF) result in increased weight loss, improved clinical stability, or decreased 30-day readmission rate?
Background: Fluid and sodium restriction are standard nonpharmacologic measures used in the management of ADHF in hospitalized patients, despite an absence of data to support their efficacy.
Study design: Randomized, controlled clinical trial with blinded outcome assessments.
Setting: A public teaching hospital in Brazil.
Synopsis: Seventy-five patients hospitalized with ADHF were randomized to receive aggressive fluid (800 mL/day) and sodium restriction (800 mg/day) or liberal intake (at least 2.5 L/day fluid, 3 to 5 g/day sodium). There were no significant between-group differences in diuretic administration. The primary outcomes of weight loss and clinical stability at three days were not significantly different between the groups. The heart-failure-specific readmission rate at 30 days was not significantly different between the groups. The aggressive restriction group had significantly worse thirst.
The study is limited by the small fraction of patients enrolled (9.2% of 813 screened) and homogenous population. Additional confirmatory trials likely are needed to change the standard of care, but this study demonstrated that aggressive fluid and sodium restriction does not benefit hospitalized patients with ADHF.
Bottom line: Aggressive fluid and sodium restriction in hospitalized patients with ADHF does not result in improved short-term weight loss, clinical stability, or decreased 30-day readmission rate, but it does cause significantly worse thirst.
Citation: Aliti GB, Rabelo ER, Clausell N, et al. Aggressive fluid and sodium restriction in acute decompensated heart failure. JAMA Intern Med. 2013;173(12):1058-1064.
Lower Rate of Pacemaker, Defibrillator Device-Pocket Hematoma without Anticoagulation Interruption
Clinical question: Is it safer to place a pacemaker or implantable cardioverter-defibrillator (ICD) while on therapeutic warfarin versus bridging with heparin/low-molecular-weight heparin (LMWH)?
Background: Current guidelines recommend bridging with heparin or LMWH for patients at high risk for thromboembolic events around the time of pacemaker or ICD placement, but it is associated with significant risk of device-pocket hematoma. Some centers place pacemakers and ICDs without interruption of warfarin. However, there are limited data to support the safety of this approach.
Study design: Multicenter, single-blinded, randomized, controlled trial.
Setting: Seventeen centers in Canada and one center in Brazil.
Synopsis: Patients with a predicted annual risk of 5% of thromboembolism were randomized to continue anticoagulation with warfarin (median INR 2.3) or to bridge therapy with heparin or LMWH; they then evaluated the incidence of clinically significant hematoma requiring prolonged hospitalization, interruption of anticoagulation therapy, or further surgical intervention. After reviewing the data on 668 patients, the Data and Safety Monitoring Board recommended termination of the study given a significantly lower rate of device-pocket hematoma in the warfarin group (3.5%) compared with the bridge group (16%) with RR 0.19 (95% CI 0.10-0.36, P<0.001). Otherwise, major surgical and thromboembolic complications were rare and not significantly different in both groups.
Bottom line: Continued warfarin therapy was associated with significantly reduced incidence of device-pocket hematoma compared with bridge with heparin or LMWH.
Citation: Birnie DH, Healey JS, Wells GA, et al. Pacemaker or defibrillator surgery without interruption of anticoagulation. N Engl J Med. 2013;368(22):2084-2093.
Prophylactic Penicillin Decreased Risk of Recurrent Leg Cellulitis
Clinical question: Does prophylactic, low-dose penicillin prevent recurrent cellulitis in patients with a history of two or more episodes of cellulitis?
Background: Some guidelines recommend prophylactic antibiotics for recurrent leg cellulitis, but there is no large randomized trial to support this practice, and clinical opinion is mixed.
Study design: Double-blinded, randomized, controlled trial.
Setting: Twenty-eight hospitals in the United Kingdom and Ireland.
Synopsis: Researchers randomized 274 patients with recurrent episodes of leg cellulitis (at least two episodes within the previous three years) to low-dose penicillin (250 mg) or placebo for 12 months and followed them for more than three years. During the prophylactic period, the penicillin group had a 45% reduction in the risk of a repeat cellulitis as compared to placebo (22% vs. 37%), equivalent to a number needed to treat to prevent a first recurrent cellulitis of five. The number of repeat episodes of cellulitis was lower overall in penicillin compared with the placebo group (119 vs. 164, P=0.02), although no significant difference was noted during the three-year follow-up period.
Factors associated with prophylaxis failure included three or more previous episodes of cellulitis, body mass index of 33 kg/m² or higher, and the presence of edema. No significant difference in adverse events was noted between the groups. Complete follow-up data was not available for participants during the follow-up period. Further study is needed to assess the long-term adverse effects and the duration of prophylaxis needed.
Bottom line: Prophylactic penicillin was effective in preventing recurrent leg cellulitis without increasing adverse effects, but its protective effect gradually declined once discontinued.
Citation: Thomas KS, Crook AM, Nunn AJ, et al. Penicillin to prevent recurrent leg cellulitis. N Engl J Med. 2013;368(18):1695-1703.
Universal ICU Decolonization Reduced Rates of MRSA Clinical Isolates and Bloodstream Infection
Clinical question: What is the most effective decolonization strategy for reducing methicillin-resistant Staphylococcus aureus (MRSA) and other pathogens in ICUs?
Background: Studies have shown that daily chlorhexidine bathing of all patients in ICUs reduced MRSA acquisition and bloodstream infection from all pathogens. However, this universal strategy has not been compared to MRSA screening and contact precautions alone, or to targeted decolonization of MRSA carriers.
Study design: Cluster-randomized comparative-effectiveness trial.
Setting: Adult ICUs in 43 Hospital Corporation of America (HCA) hospitals in 16 states.
Synopsis: All adult ICUs in a given hospital were randomized to one of three infection prevention strategies: Group 1 continued MRSA screening and isolation; Group 2 performed screening, isolation, and decolonization of MRSA carriers; and Group 3 implemented universal decolonization with intranasal mupirocin and daily bathing with chlorhexidine-impregnated cloths but no screening.
Forty-three hospitals, including 74 ICUs and 74,256 patients, underwent randomization. Significant reductions in the primary outcome of ICU-attributable MRSA clinical isolates (excluding MRSA screening tests) and the secondary outcome of bloodstream infection due to any pathogen were demonstrated across the three groups. One bloodstream infection was prevented for every 54 patients who underwent decolonization. Formal cost-effectiveness analysis was not performed.
Bottom line: In the ICU, universal decolonization was more effective than screening and isolation or targeted decolonization in the reduction of clinical MRSA isolates and bloodstream infection due to any pathogen, although monitoring for emerging resistance is necessary.
Citation: Huang SS, Septimus E, Kleinman K, et al. Targeted versus universal decolonization to prevent ICU infection. N Engl J Med. 2013;368(24):2255-2265.
Intensive Blood-Pressure Lowering in Intracerebral Hemorrhage Did Not Reduce Death or Severe Disability
Clinical question: What is the efficacy and safety of early intensive blood-pressure lowering in patients with acute intracerebral hemorrhage?
Background: After intracerebral hemorrhage, blood pressure often becomes elevated and is a predictor of outcome. It is not known whether rapid lowering of blood pressure would improve outcome.
Study design: International, multicenter, prospective, randomized, open-treatment, blinded end-point trial.
Setting: One hundred forty-four hospitals in 21 countries.
Synopsis: Researchers randomly assigned 2,839 patients with intracerebral hemorrhage in the previous six hours to intensive blood-pressure lowering with target systolic blood pressure of <140 mmHg within one hour, or guideline-recommended treatment with target systolic blood pressure of <180 mmHg. The mean systolic blood pressure achieved was 150 mmHg in the intensive-treatment group and 164 mmHg in the standard-treatment group.
There was no significant difference between the two groups in the primary outcome of death or major disability. A pre-specified ordinal analysis of modified Rankin score (score of 0 indicates no symptoms; a score of 5 indicates severe disability) did show significantly lower modified Rankin scores with intensive treatment. There was no difference between the two groups in the rate of serious adverse events.
Bottom line: Early intensive blood-pressure lowering in patients with acute intracerebral hemorrhage did not reduce death or major disability, although there may be improved functional outcomes with intensive blood-pressure lowering.
Citation: Anderson CS, Heeley E, Huang Y, et al. Rapid blood-pressure lowering in patients with acute intracerebral hemorrhage. N Engl J Med. 2013;368(25):2355-2365.