Stress ulcer prophylaxis with proton pump inhibitor (pantoprazole) in adult critically ill patients in the intensive care unit: A randomized, blinded, placebocontrolled trial

Phase 3

Completed

• Conditions: 10024970; stomach ulcer; stress ulcer; 10018031

• Registration Number: NL-OMON42819
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

Adult patients admitted to the ICU with one or more of the following acute conditions: shock, renal replacement therapy, mechanical ventilation expected to last > 24 hours, any kind of coagulopathy, treatment with anticoagulant drugs or liver disease.

Exclusion Criteria

contraindications to PPI, daily treatment with PPI and/or histamine-2-receptor antagonist, GI bleeding of any origin or known peptic ulcer during current hospital admission, organ transplant, withdrawal from active therapy or brain death, positive urine human chorionic gonadotropin (hCG) or plasma hCG or consent according to national regulations not obtainable

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome: Mortality 90 days after randomization. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes: proportion of patients with clinically important GI<br /><br>bleeding, pneumonia, Clostridium difficile infection and myocardial ischemia,<br /><br>proportion of patients with clinically important GI bleeding, proportion of<br /><br>patients with pneumonia or clostridium difficile infections, 1 year mortality<br /><br>post-randomization, days alive without organ support in the 90-day period,<br /><br>serious adverse reactions and a health economic analysis.</p><br>