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 JC Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, CH 3010, Bern, Switzerland. joerg.schefold@insel.ch.
- Perner A Department of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
- Lange T Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.
- Wetterslev J Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.
- Wise MP Department of Adult Critical Care, University Hospital of Wales, Cardiff, UK.
- Borthwick M Pharmacy Department, Oxford University Hospitals NHS Trust, Oxford, UK.
- Bendel S Department of Intensive Care Medicine, Kuopio University Hospital, Kuopio, Finland.
- Keus F Department of Critical Care, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
- Guttormsen AB Department of Anaesthesia and Intensive Care, Haukeland University Hospital and Clinical Institute 1 UiB, Bergen, Norway.
- Marker S Department of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
- Krag M Department of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
- Møller MH Department of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, Copenhagen, 2100, Denmark.
- 2018-01-12
Published in:
- Trials. - 2018
Acute kidney injury
Acute renal failure
Dialysis
Pantoprazole
Sepsis
Acute Kidney Injury
Gastrointestinal Hemorrhage
Humans
Intensive Care Units
Multicenter Studies as Topic
Observational Studies as Topic
Outcome Assessment, Health Care
Peptic Ulcer
Pragmatic Clinical Trials as Topic
Proton Pump Inhibitors
Renal Replacement Therapy
Stress, Psychological
English
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.
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.
- Language
-
- English
- Open access status
- gold
- Identifiers
-
- DOI 10.1186/s13063-017-2408-3
- PMID 29321041
- Persistent URL
- https://susi.usi.ch/global/documents/292762
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