EUCTR2015‐000318‐24‐DK.

Trial name or title	Stress ulcer prophylaxis in the intensive care unit
Methods	Parallel‐group double‐blind randomised controlled study
Participants	Inclusion criteria Acute admission to the ICU AND Aged ≥ 18 years AND One or more of the following risk factors: Shock (continuous infusion with vasopressors or inotropes, systolic blood pressure < 90 mmHg, mean arterial blood pressure < 70 mmHg, or lactate > 4 mmol/L) Acute or chronic intermittent or continuous renal replacement therapy Invasive mechanical ventilation, which is expected to last > 24 hours. When in doubt of the forecast, the patient should be enrolled Coagulopathy (platelets < 50 × 10⁹/L or international normalized ratio (INR) > 1.5 or prothrombin time (PT) > 20 seconds) documented within the last 24 hours Ongoing treatment with anticoagulant drugs (prophylaxis doses excluded) History of coagulopathy (platelets < 50 × 10⁹/L or INR > 1.5 or PT > 20 seconds within 6 months before hospital admission History of chronic liver disease (portal hypertension, cirrhosis proven by biopsy, computed tomography (CT) scan or ultrasound, history of variceal bleeding or hepatic encephalopathy in the past medical history) Exclusion criteria Contraindications to PPI Ongoing treatment with PPI and/or H2RA on a daily basis GI bleeding of any origin during current hospital admission Peptic ulcer diagnosed during current hospital admission Organ transplant during current hospital admission Withdrawal from active therapy or brain death Fertile woman with positive urine human chorionic gonadotropin (hCG) or plasma‐hCG Consent according to national regulations not obtainable
Interventions	Intervention: 4 mL pantoprazole IV Control: placebo
Outcomes	Primary outcomes Mortality Secondary outcomes Adverse events: clinically important gastrointestinal bleeding, pneumonia, Clostridium difficile infection, or acute myocardial ischaemia in the ICU Clinically significant GI bleeding in the ICU One or more infectious adverse events (pneumonia or Clostridium difficile infection) in the ICU 1‐Year “landmark” mortality post randomisation Days alive without use of mechanical ventilation, renal replacement therapy, or circulatory support in the 90‐day period Number of SARs Health economic analysis. Analytical details will be based on results of the study and will be specified (cost‐benefit vs cost‐minimisation analyses)
Starting date	August 2016
Contact information	Morten Hylander; mortenhylander@gmail.com
Notes	clinicaltrialsregister.eu/ctr‐search/search?query=EUCTR2015‐000318‐24‐DK