Effects of stress ulcer prophylaxis in adult ICU patients receiving renal replacement therapy (Sup-Icu RENal, SIREN): Study protocol for a pre-planned observational study.

Schefold, Joerg C.; Perner, Anders; Lange, Theis; Wetterslev, Jørn; Wise, Matt P; Borthwick, Mark; Bendel, Stepani; Keus, Frederik; Guttormsen, Anne Berit; Marker, Søren; Krag, Mette; Møller, Morten Hylander (2018). Effects of stress ulcer prophylaxis in adult ICU patients receiving renal replacement therapy (Sup-Icu RENal, SIREN): Study protocol for a pre-planned observational study. Trials, 19(1), p. 26. BioMed Central 10.1186/s13063-017-2408-3

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BACKGROUND Proton pump inhibitors are often used in critically ill patients to prevent gastrointestinal bleeding despite limited evidence for benefit. Patients with acute kidney injury requiring renal replacement therapy (RRT) are at high risk of gastrointestinal bleeding as (pre-)uremia induces coagulopathy through effects on platelets and coagulation cascades. No high-quality randomized clinical trials have previously assessed the benefits and harms of prophylactic proton pump inhibitor use in this high-risk population of adult critically ill patients. METHODS/DESIGN Among the 3350 patients included in the Stress Ulcer Prophylaxis in the Intensive Care Unit (SUP-ICU) trial-an investigator-initiated international randomized clinical trial on prophylactic proton pump inhibitor versus placebo in acutely admitted adult ICU patients at risk of gastrointestinal bleeding-we will compare the benefits and harms of prophylactic use of proton pump inhibitor in patients in need of RRT versus those not requiring this treatment. We will determine the proportion of patients with clinically important bleeding, the proportion of patients with adverse events including pneumonia, Clostridium difficile enteritis, or acute myocardial ischemia in the ICU, as well as transfusion requirements. Moreover, 90 day and 365 day mortality post-randomization will be investigated. As a secondary analysis, we will examine the association between acute kidney injury and RRT during ICU stay and gastrointestinal bleeding. DISCUSSION With the outlined predefined analysis, we will characterize the balance between the benefits and harms of stress ulcer prophylaxis in acutely admitted adult ICU patients in need of RRT, including the potential interaction of allocation to proton pump inhibitor versus placebo. TRIAL REGISTRATION ClinicalTrials.gov, NCT02718261 . Registered on 14 March 2016.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Intensive Care, Emergency Medicine and Anaesthesiology (DINA) > Clinic of Intensive Care

UniBE Contributor:

Schefold, Joerg C.

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1745-6215

Publisher:

BioMed Central

Language:

English

Submitter:

Mirella Aeberhard

Date Deposited:

09 Apr 2018 13:55

Last Modified:

23 Oct 2019 22:59

Publisher DOI:

10.1186/s13063-017-2408-3

PubMed ID:

29321041

Uncontrolled Keywords:

Acute kidney injury Acute renal failure Dialysis Pantoprazole Sepsis

BORIS DOI:

10.7892/boris.109093

URI:

https://boris.unibe.ch/id/eprint/109093

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