Stress ulcer prophylaxis with a proton pump inhibitor versus placebo in critically ill patients (SUP-ICU trial): study protocol for a randomised controlled trial

Trials. 2016 Apr 19;17(1):205. doi: 10.1186/s13063-016-1331-3.

Abstract

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.

Trial registration: ClinicalTrials.gov Identifier: NCT02467621 .

Keywords: Adverse event; Critically ill; Gastrointestinal bleeding; Intensive care unit; Placebo; Randomised clinical trial; Stress ulcer prophylaxis.

Publication types

  • Pragmatic Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Anti-Ulcer Agents / administration & dosage*
  • Anti-Ulcer Agents / adverse effects
  • Anti-Ulcer Agents / economics
  • Clinical Protocols
  • Cost-Benefit Analysis
  • Critical Illness
  • Cross Infection / etiology
  • Drug Administration Schedule
  • Drug Costs
  • Enterocolitis, Pseudomembranous / etiology
  • Europe
  • Hospital Costs
  • Humans
  • Myocardial Ischemia / etiology
  • Peptic Ulcer / economics
  • Peptic Ulcer / etiology
  • Peptic Ulcer / mortality
  • Peptic Ulcer / prevention & control*
  • Peptic Ulcer Hemorrhage / economics
  • Peptic Ulcer Hemorrhage / etiology
  • Peptic Ulcer Hemorrhage / mortality
  • Peptic Ulcer Hemorrhage / prevention & control*
  • Pneumonia / etiology
  • Proton Pump Inhibitors / administration & dosage*
  • Proton Pump Inhibitors / adverse effects
  • Proton Pump Inhibitors / economics
  • Research Design
  • Risk Factors
  • Time Factors
  • Treatment Outcome

Substances

  • Anti-Ulcer Agents
  • Proton Pump Inhibitors

Associated data

  • ClinicalTrials.gov/NCT02467621