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	Stress ulcer prophylaxis in the intensive care unit trial: detailed statistical analysis plan
	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. ; Moller, M. H.
	2017
关键词	PROTON-PUMP INHIBITORS CLOSTRIDIUM-DIFFICILE INFECTION CRITICALLY-ILL PATIENTS RANDOMIZED CONTROLLED-TRIAL 2 RECEPTOR ANTAGONISTS III PATIENTS METAANALYSIS RISK CLOPIDOGREL OUTCOMES
英文摘要	BackgroundIn 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). MethodsThe 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. ConclusionStress 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.; Innovation Fund Denmark [4108-00011B]; Aase and Ejnar Danielsens Foundation [10-001020]; Ehrenreichs Foundation [6000567]; Scandinavian Society of Anaesthesia and Intensive Care Medicine (SSAI); Danish Society of Anaesthesiology and Intensive Care Medicine (DASAIM); Danish Medical Association; European Society of Intensive Care Medicine; Danish Regions Research Foundation (Medicinpuljen) [16/2885]; Research Foundation of the Capital Region of Denmark; SCI(E); ARTICLE; 7; 859-868; 61
语种	英语
出处	SCI
出版者	ACTA ANAESTHESIOLOGICA SCANDINAVICA
内容类型	其他
源URL	[http://hdl.handle.net/20.500.11897/471917]
专题	数学科学学院
推荐引用方式 GB/T 7714	Krag, M.,Perner, A.,Wetterslev, J.,et al. Stress ulcer prophylaxis in the intensive care unit trial: detailed statistical analysis plan. 2017-01-01.

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