Abstract
BackgroundStress ulcer prophylaxis is considered standard of care in many critically ill patients in the intensive care unit (ICU). However, the quality of evidence supporting this has recently been questioned, and clinical equipoise exists. Whether there is overall benefit or harm of stress ulcer prophylaxis in adult hospitalised acutely ill patients is unknown. Accordingly, we aim to assess patient-important benefits and harms of stress ulcer prophylaxis versus placebo or no treatment in adult hospitalised acutely ill patients with high risk of gastrointestinal bleeding irrespective of hospital setting.Methods/designWe will conduct a systematic review of randomised clinical trials with meta-analysis and trial sequential analysis and assess use of proton pump inhibitors (PPIs) or histamine-2-receptor antagonists (H2RAs) in any dose, formulation and duration. We will accept placebo or no prophylaxis as control interventions. The participants will be adult hospitalised acutely ill patients with high risk of gastrointestinal bleeding.We will systematically search the Cochrane Library, MEDLINE, EMBASE, Science Citation Index, BIOSIS and Epistemonikos for relevant literature. We will follow the recommendations by the Cochrane Collaboration and the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) statement. The risk of systematic errors (bias) and random errors will be assessed, and the overall quality of evidence will be evaluated using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach.DiscussionThere is a need for a high-quality systematic review to summarise the benefits and harms of stress ulcer prophylaxis in hospitalised patients to inform practice and future research. Although stress ulcer prophylaxis is used worldwide, no firm evidence for benefit or harm as compared to placebo or no treatments has been established. Critical illness is a continuum not limited to the ICU setting, which is why it is important to assess the benefits and harms of stress ulcer prophylaxis in a wider perspective than exclusively in ICU patients.Systematic review registrationPROSPERO CRD42017055676
Highlights
Stress ulcer prophylaxis is considered standard of care in many critically ill patients in the intensive care unit (ICU)
The reported estimates often include all conditions resulting in gastrointestinal bleeding and not exclusively stress ulcers and other bleedings prevented by acid suppressants
Study registration This protocol has been prepared according to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines [34], and the review has been registered in the International Prospective Register of Systematic Reviews (PROSPERO)
Summary
Stress ulcer prophylaxis is considered standard of care in many critically ill patients in the intensive care unit (ICU). After 3 days of stay in the intensive care unit (ICU), the majority of patients have developed endoscopically evident signs of gastrointestinal ulcerations [2, 3]. These stress ulcerations are typically superficial and asymptomatic, but 1 in 20 will progress and erode larger vessels resulting in overt gastrointestinal bleeding [4, 5]. In a cohort study by Cook et al [11], stress ulceration was identified as the sole source of gastrointestinal bleeding by endoscopy in less than 50% of the patients, suggesting that other causes of gastrointestinal bleeding, not prevented by stress ulcer prophylaxis, are frequent. This highlights the need for placebo-controlled trials to ensure assessment of stress ulcer-induced bleedings only
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