Prophylaxis of stress related gastrointestinal bleeding in the intensive care unit.

Phase 1

• Conditions: Prophylaxis of stress related gastrointestinal bleeding among critically ill patients in the intensive care unit.; MedDRA version: 19.1Level: PTClassification code 10022519Term: Intensive careSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 19.1Level: LLTClassification code 10071910Term: Upper gastrointestinal bleedingSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2015-000318-24-DK
• Lead Sponsor: Dept. of Intensive Care 4131, Copenhagen University Hospital Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-11
• Last Update Posted: 29 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 3350

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)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1850

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified