Stress Ulcer Prophylaxis in the Intensive Care Unit

• Status: Completed
• Trial end date: 2018-01-21
• Target enrollment: 0
• Participant gender: All

Summary

Stress ulcer prophylaxis (SUP) is standard of care in the intensive care unit (ICU), however the quantity and quality of evidence is low and potential harm has been reported.

The aim of the SUP-ICU trial is to asses the overall benefits and harms of SUP with proton pump inhibitor in adult critically ill patients in the ICU.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Morten Hylander Møller
• Collaborators: Copenhagen Trial Unit, Center for Clinical Intervention Research; Rigshospitalet, Denmark
• Treatments: Pantoprazole; Proton Pump Inhibitors

Criteria

INCLUSION CRITERIA:

• Acute admission to the ICU

• Age ≥ 18 years

• 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

• Coagulopathy (platelets < 50 x 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 x 109/l or INR > 1.5 or PT > 20 seconds) within 6 months prior to 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

• Diagnosed with peptic ulcer 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