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

TY - JOUR

T1 - Stress ulcer prophylaxis with a proton pump inhibitor versus placebo in critically ill patients (SUP-ICU trial)

T2 - study protocol for a randomised controlled trial

AU - Krag, Mette

AU - Perner, Anders

AU - Wetterslev, Jørn

AU - Wise, Matt P

AU - Borthwick, Mark

AU - Bendel, Stepani

AU - Pelosi, Paolo

AU - Keus, Frederik

AU - Guttormsen, Anne Berit

AU - Schefold, Joerg C.

AU - Møller, Morten Hylander

AU - SUP-ICU investigators

PY - 2016/4/19

Y1 - 2016/4/19

N2 - 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 .

AB - 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 .

KW - Anti-Ulcer Agents

KW - Clinical Protocols

KW - Cost-Benefit Analysis

KW - Critical Illness

KW - Cross Infection

KW - Drug Administration Schedule

KW - Drug Costs

KW - Enterocolitis, Pseudomembranous

KW - Europe

KW - Hospital Costs

KW - Humans

KW - Myocardial Ischemia

KW - Peptic Ulcer

KW - Peptic Ulcer Hemorrhage

KW - Pneumonia

KW - Proton Pump Inhibitors

KW - Research Design

KW - Risk Factors

KW - Time Factors

KW - Treatment Outcome

KW - Journal Article

KW - Pragmatic Clinical Trial

KW - Randomized Controlled Trial

KW - Research Support, Non-U.S. Gov't

U2 - 10.1186/s13063-016-1331-3

DO - 10.1186/s13063-016-1331-3

M3 - Journal article

C2 - 27093939

SN - 1745-6215

VL - 17

JO - Trials

JF - Trials

IS - 1

M1 - 205

ER -