Stress Ulcer Prophylaxis in the Intensive Care Unit (SUP-ICU)
Background: Critically ill patients in the intensive care unit (ICU) are at risk of clinically important gastrointestinal
bleeding, and acid suppressants are frequently used prophylactically. However, stress ulcer prophylaxis may increase
the risk of serious adverse events and, additionally, the quantity and quality of evidence supporting the use of
stress ulcer prophylaxis is low. The aim of the SUP-ICU trial is to assess the benefits and harms of stress ulcer
prophylaxis with a proton pump inhibitor in adult patients in the ICU. We hypothesise that stress ulcer prophylaxis
reduces the rate of gastrointestinal bleeding, but increases rates of nosocomial infections and myocardial ischaemia.
The overall effect on mortality is unpredictable.
Methods/design: The SUP-ICU trial is an investigator-initiated, pragmatic, international, multicentre, randomised,
blinded, parallel-group trial of stress ulcer prophylaxis with a proton pump inhibitor versus placebo (saline) in 3350
acutely ill 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 in the 90-day
period, serious adverse reactions, 1-year mortality, and health economic analyses.
The sample size will enable us to detect a 20 % relative risk difference (5 % absolute risk difference) in 90-day
mortality assuming a 25 % event rate with a risk of type I error of 5 % and power of 90 %. The trial will be
externally monitored according to Good Clinical Practice standards. Interim analyses will be performed after 1650
and 2500 patients.
Conclusion: The SUP-ICU trial will provide high-quality data on the benefits and harms of stress ulcer prophylaxis
with a proton pump inhibitor in critically ill adult patients admitted in the ICU.