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Published in: Systematic Reviews 1/2017

Open Access 01-12-2017 | Protocol

Stress ulcer prophylaxis versus placebo or no prophylaxis in adult hospitalised acutely ill patients—protocol for a systematic review with meta-analysis and trial sequential analysis

Authors: Søren Marker, Anders Perner, Jørn Wetterslev, Marija Barbateskovic, Janus Christian Jakobsen, Mette Krag, Anders Granholm, Carl Thomas Anthon, Morten Hylander Møller

Published in: Systematic Reviews | Issue 1/2017

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Abstract

Background

Stress 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/design

We 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.

Discussion

There 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 registration

PROSPERO CRD42017055676
Appendix
Available only for authorised users
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Metadata
Title
Stress ulcer prophylaxis versus placebo or no prophylaxis in adult hospitalised acutely ill patients—protocol for a systematic review with meta-analysis and trial sequential analysis
Authors
Søren Marker
Anders Perner
Jørn Wetterslev
Marija Barbateskovic
Janus Christian Jakobsen
Mette Krag
Anders Granholm
Carl Thomas Anthon
Morten Hylander Møller
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Systematic Reviews / Issue 1/2017
Electronic ISSN: 2046-4053
DOI
https://doi.org/10.1186/s13643-017-0509-4

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