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.
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Details
1 Inselspital, Bern University Hospital, University of Bern, Department of Intensive Care Medicine, Bern, Switzerland
2 Copenhagen University Hospital, Rigshospitalet, Department of Intensive Care 4131, Copenhagen, Denmark (GRID:grid.475435.4); Copenhagen University Hospital, Rigshospitalet, Centre for Research in Intensive Care, Copenhagen, Denmark (GRID:grid.475435.4)
3 University of Copenhagen, Section of Biostatistics, Copenhagen, Denmark (GRID:grid.5254.6) (ISNI:0000 0001 0674 042X)
4 Copenhagen University Hospital Rigshospitalet, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen, Denmark (GRID:grid.475435.4)
5 University Hospital of Wales, Department of Adult Critical Care, Cardiff, UK (GRID:grid.241103.5) (ISNI:0000 0001 0169 7725)
6 Oxford University Hospitals NHS Trust, Pharmacy Department, Oxford, UK (GRID:grid.410556.3) (ISNI:0000 0001 0440 1440)
7 Kuopio University Hospital, Department of Intensive Care Medicine, Kuopio, Finland (GRID:grid.410705.7) (ISNI:0000 0004 0628 207X)
8 University Medical Center Groningen, University of Groningen, Department of Critical Care, Groningen, The Netherlands (GRID:grid.410705.7)
9 Haukeland University Hospital and Clinical Institute 1 UiB, Department of Anaesthesia and Intensive Care, Bergen, Norway (GRID:grid.412008.f) (ISNI:0000 0000 9753 1393)
10 Copenhagen University Hospital, Rigshospitalet, Department of Intensive Care 4131, Copenhagen, Denmark (GRID:grid.475435.4)