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01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Trials 1/2018

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

Zeitschrift:
Trials > Ausgabe 1/2018
Autoren:
Joerg C. Schefold, Anders Perner, Theis Lange, Jørn Wetterslev, Matt P. Wise, Mark Borthwick, Stepani Bendel, Frederik Keus, Anne Berit Guttormsen, Søren Marker, Mette Krag, Morten Hylander Møller, for the SUP-ICU investigators
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:https://​doi.​org/​10.​1186/​s13063-017-2408-3) contains supplementary material, which is available to authorized users.

Abstract

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.
Zusatzmaterial
Additional file 1: STROBE statement. (DOC 85 kb)
13063_2017_2408_MOESM1_ESM.doc
Additional file 2: SPIRIT 2013 checklist. (DOC 121 kb)
13063_2017_2408_MOESM2_ESM.doc
Literatur
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