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- Title
Stress ulcer prophylaxis in the intensive care unit trial: detailed statistical analysis plan.
- Authors
Krag, M.; Perner, A.; Wetterslev, J.; Lange, T.; Wise, M. P.; Borthwick, M.; Bendel, S.; Pelosi, P.; Keus, F.; Guttormsen, A. B.; Schefold, J. C.; Meyhoff, T. S.; Marker, S.; Møller, M. H.
- Abstract
<bold>Background: </bold>In this statistical analysis plan, we aim to provide details of the pre-defined statistical analyses of the Stress Ulcer Prophylaxis in the Intensive Care Unit (SUP-ICU) trial. The aim of the SUP-ICU trial is to assess benefits and harms of stress ulcer prophylaxis with a proton pump inhibitor in adult patients in the intensive care unit (ICU).<bold>Methods: </bold>The SUP-ICU trial is an investigator-initiated, international, multicentre, randomised, blinded, parallel-group trial of intravenously pantoprazole 40 mg once daily vs. placebo in 3350 acutely ill adult ICU patients at risk of gastrointestinal bleeding. The primary outcome measure is 90-day mortality. Secondary outcomes include the proportion of patients with clinically important gastrointestinal bleeding, pneumonia, Clostridium difficile infection or myocardial ischaemia, days alive without life support, serious adverse reactions, 1-year mortality, and a health economic analysis. Two formal interim analyses will be performed. The statistical analyses will be conducted according to the outlined pre-defined statistical analysis plan. The primary analysis will be a logistic regression analysis adjusted for stratification variables comparing the two intervention groups in the intention-to-treat population. In a secondary analysis, we will additionally adjust the primary outcome for potential random differences in baseline characteristics. The conclusion will be based on the intention-to-treat population.<bold>Conclusion: </bold>Stress ulcer prophylaxis is standard of care in ICUs worldwide, but has never been tested in large high-quality randomised placebo-controlled trials. The SUP-ICU trial will provide important high-quality data on the balance between the benefits and harms of stress ulcer prophylaxis in adult critically ill patients.
- Subjects
DENMARK; ITALY; ULCER treatment; PREVENTIVE medicine; INTENSIVE care units; CRITICALLY ill; CLOSTRIDIOIDES difficile; PLACEBOS; PHYSIOLOGICAL stress; PEPTIC ulcer prevention; SULFUR compounds; PROTON pump inhibitors; CATASTROPHIC illness; COMPARATIVE studies; CRITICAL care medicine; RESEARCH methodology; MEDICAL cooperation; RESEARCH; STATISTICS; DATA analysis; EVALUATION research; RANDOMIZED controlled trials; THERAPEUTICS
- Publication
Acta Anaesthesiologica Scandinavica, 2017, Vol 61, Issue 7, p859
- ISSN
0001-5172
- Publication type
journal article
- DOI
10.1111/aas.12917