EUCTR2015-000318-24-DK
Active, not recruiting
Phase 1
Stress Ulcer Prophylaxis in the Intensive Care Unit - SUP-IC
Dept. of Intensive Care 4131, Copenhagen University Hospital Rigshospitalet0 sites3,350 target enrollmentMarch 11, 2015
DrugsPantoprazol
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Dept. of Intensive Care 4131, Copenhagen University Hospital Rigshospitalet
- Enrollment
- 3350
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Acute admission to the ICU AND
- •Aged \= 18 years AND
- •One or more of the following risk factors:
- •1\.Shock (continuous infusion with vasopressors or inotropes, systolic blood pressure \< 90 mmHg, mean arterial blood pressure \< 70 mmHg or lactate \> 4 mmol/l)
- •2\.Acute or chronic intermittent or continuous renal replacement therapy
- •3\.Invasive mechanically ventilation which is expected to last \> 24 hours. When in doubt of the forecast, the patient should be enrolled.
- •4\.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
- •5\.Ongoing treatment with anticoagulant drugs (prophylaxis doses excluded)
- •6\.History of coagulopathy (platelets \< 50 x 109/l or INR \> 1\.5 or PT \> 20 seconds within 6 months prior to hospital admission
- •7\. 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
Outcomes
Primary Outcomes
Not specified
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