Timing of onset of gastrointestinal bleeding in the ICU: Protocol for a preplanned observational study

Acta Anaesthesiologica Scandinavica
Anders GranholmM H Møller

Abstract

Critically ill patients are at risk of gastrointestinal bleeding, but clinically important gastrointestinal bleeding is rare. The majority of intensive care unit (ICU) patients receive stress ulcer prophylaxis (SUP), despite uncertainty concerning the balance between benefit and harm. For approximately half of ICU patients with gastrointestinal bleeding, onset is early, ie within the first two days of the ICU stay. The aetiology of gastrointestinal bleeding and consequently the balance between benefit and harm of SUP may differ between patients with early vs late gastrointestinal bleeding. This is a protocol and statistical analysis plan for a preplanned exploratory substudy of the Stress Ulcer Prophylaxis in the Intensive Care Unit (SUP-ICU) randomized clinical trial, comparing intravenous pantoprazole (40 mg once daily) with placebo in 3350 acutely ill adult ICU patients. We will describe baseline characteristics and assess the time to onset of the first clinically important episode of GI bleeding accounting for survival status and allocation to SUP or placebo. In addition, we will describe differences in therapeutic and diagnostic procedures used in patients with clinically important gastrointestinal bleeding according to ea...Continue Reading

References

Dec 22, 1993·JAMA : the Journal of the American Medical Association·J R Le GallF Saulnier
Dec 12, 2001·Critical Care : the Official Journal of the Critical Care Forum·D J CookUNKNOWN Canadian Critical Care Trials Group
Feb 20, 2010·BMJ : British Medical Journal·Elizabeth LoderDomhnall Macauley
Aug 23, 2012·JAMA : the Journal of the American Medical Association·Laine Thomas, Eric D Peterson
May 21, 2013·Intensive Care Medicine·Aurélien VesinJean Francois Timsit
Feb 21, 2014·Science Translational Medicine·Rafael Dal-RéElisabete Weiderpass
Aug 27, 2014·PLoS Medicine·UNKNOWN PLOS Medicine Editors
Jan 20, 2017·Intensive Care Medicine·Andrew RhodesR Phillip Dellinger
Jun 14, 2017·Acta Anaesthesiologica Scandinavica·M KragM H Møller

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Citations

Jul 10, 2019·Acta Anaesthesiologica Scandinavica·Søren MarkerUNKNOWN SUP-ICU trial investigators
Aug 24, 2019·Acta Anaesthesiologica Scandinavica·Anders GranholmMorten Hylander Møller
Jan 5, 2021·Current Opinion in Critical Care·Hasan M Al-Dorzi, Yaseen M Arabi

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