Conditions: Stress Ulcer Prophylaxis
Keywords: SUP Upper GI bleeding Seriously ill patients
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 343
Healthy volunteers: no

Brief summary:
The efficacy of esomeprazole will be compared versus cimetidine (a drug that previously demonstrated prevention of bleeding events) during treatment period in proportion of patients for the prevention of upper GI bleeding.

Detailed description:
Stress related upper Gastrointestinal (GI) bleedings are important events associated with morbidity and mortality among seriously ill patients. Data from the literature suggest that stress ulcer prevention with effective acid suppressive treatment can reduce bleeding events and is thus an important therapy in high-risk patients. Esomeprazole has the potential to reduce gastric acidity for prolonged periods of time adequate for both preventing mucosal damage and facilitating coagulation. This study is to reveal whether intravenous (iv) esomeprazole is effective in preventing upper gastrointestinal bleeding and if it is tolerated by Chinese seriously ill patients.

Arms:
arm 1: iv esomeprazole 30 min intermittent infusions given for maximum 14 days arm 2: iv cimetidine 30 min bolus infusion followed by iv cimetidine continuous infusion given for maximum 14 days

Interventions: intervention 1: Esomeprazole intervention 2: Cimetidine
Intervention descriptions: intervention 1: iv esomeprazole 30 min intermittent infusions given for maximum 14 days intervention 2: iv cimetidine 30 min bolus infusion followed by iv cimetidine continuous infusion given for maximum 14 days

Protocol document: