Article

Stress ulcer prophylaxis versus placebo or no prophylaxis in critically ill patients : A systematic review of randomised clinical trials with meta-analysis and trial sequential analysis.

Department of Intensive Care, Copenhagen University Hospital Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.
European Journal of Intensive Care Medicine (Impact Factor: 5.54). 10/2013; DOI: 10.1007/s00134-013-3125-3
Source: PubMed

ABSTRACT To assess the effects of stress ulcer prophylaxis (SUP) versus placebo or no prophylaxis on all-cause mortality, gastrointestinal (GI) bleeding and hospital-acquired pneumonia in adult critically ill patients in the intensive care unit (ICU).
We performed a systematic review using meta-analysis and trial sequential analysis (TSA). Eligible trials were randomised clinical trials comparing proton pump inhibitors or histamine 2 receptor antagonists with either placebo or no prophylaxis. Two reviewers independently assessed studies for inclusion and extracted data. The Cochrane Collaboration methodology was used. Risk ratios/relative risks (RR) with 95 % confidence intervals (CI) were estimated. The predefined outcome measures were all-cause mortality, GI bleeding, and hospital-acquired pneumonia.
Twenty trials (n = 1,971) were included; all were judged as having a high risk of bias. There was no statistically significant difference in mortality (fixed effect: RR 1.00, 95 % CI 0.84-1.20; P = 0.87; I (2) = 0 %) or hospital-acquired pneumonia (random effects: RR 1.23, 95 % CI 0.86-1.78; P = 0.28; I (2) = 19 %) between SUP patients and the no prophylaxis/placebo patients. These findings were confirmed in the TSA. With respect to GI bleeding, a statistically significant difference was found in the conventional meta-analysis (random effects: RR 0.44, 95 % CI 0.28-0.68; P = 0.01; I (2) = 48 %); however, TSA (TSA adjusted 95 % CI 0.18-1.11) and subgroup analyses could not confirm this finding.
This systematic review using meta-analysis and TSA demonstrated that both the quality and the quantity of evidence supporting the use of SUP in adult ICU patients is low. Consequently, large randomised clinical trials are warranted.

0 Followers
 · 
52 Views
  • Source
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Bleeding from stress-related mucosal disease in critically ill patients remains an important clinical management issue. Although only a small proportion (1-6%) of patients admitted to an intensive care unit (ICU) will bleed, a substantial proportion exhibit clinical risk factors (mechanical ventilation for >48 h and a coagulopathy) that predict an increased risk of bleeding. Furthermore, upper gastrointestinal mucosal lesions can be found in 75-100% of patients in ICUs. Although uncommon, stress-ulcer bleeding is a severe complication with an estimated mortality of 40-50%, mostly from decompensating an underlying condition or multiorgan failure. Although the vast majority of patients in ICUs receive stress-ulcer prophylaxis, largely with PPIs, some controversy surrounds their efficacy and safety. Indeed, no single trial has shown that stress-ulcer prophylaxis reduces mortality. Some reports suggest that the use of PPIs increases the risk of nosocomial infections. However, several meta-analyses and cost-effectiveness studies suggest PPIs to be more clinically effective and cost-effective than histamine-2 receptor antagonists, without considerable increases in nosocomial pneumonia. To help clinicians use the most appropriate strategy for treatment of patients in the ICU, this Review presents the latest information on all aspects of stress-related mucosal disease.
    Nature Reviews Gastroenterology &#38 Hepatology 01/2015; DOI:10.1038/nrgastro.2014.235 · 10.81 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: ARDS is a common, lethal, and morbid respiratory complication primarily seen in the setting of major trauma and infection. Despite advances in mechanical ventilation for ARDS, many interventions have not been successful in reducing mortality. Recent grant announcements and ongoing clinical trials indicate an interest in preventing ARDS. This Perspective challenges some of the basic assumptions of ARDS prevention and preventive care in the ICU. ARDS is an organ function surrogate outcome. Studies of surrogate outcomes in medicine have repeatedly failed to show an association with patient centered outcomes that might include mortality, quality of life, patient satisfaction, and cost. Organ failure surrogate outcomes in critical care including oxygenation, cardiac output, and blood pressure have similarly failed to show a consistent association with patient centered benefit. Trials designed to demonstrate an effect on surrogate outcomes will rarely be able to demonstrate small, but important, harms so that the net benefit of prevention can be calculated. This will leave clinicians with insufficient information to balance the unknown benefits of ARDS prevention with imprecisely estimated costs or risks of prevention. Because ARDS diagnosis relies on oxygenation and the chest radiograph that might be directly influenced by the prophylactic intervention, studies must be designed to insure that the prevention is not merely cosmetic. Strategies that prevent ARDS need to be tested in trials sufficiently powered to demonstrate their patient centered costs, benefits and harms before widespread adoption.
    American Journal of Respiratory and Critical Care Medicine 12/2014; DOI:10.1164/rccm.201408-1574CP · 11.99 Impact Factor