Stress Ulcer Prophylaxis of Intravenous Esomeprazole in Chinese Seriously Ill Patients

Effect of Intravenous Esomeprazole Versus Cimetidine in Prevention of Stress Ulcer Prophylaxis in Chinese Seriously Ill Patients - a Randomized, Double-blind, Parallel-group Study

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.

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.

Inclusion Criteria:

1. Critically ill patients
2. Requirement for mechanical ventilation
3. At least one major risk factor for stress ulcer related bleeding

Exclusion Criteria:

1. History of gastric or oesophageal surgery
2. Evidence of active GI bleeding
3. Advanced renal disease
4. Treatment with any Proton Pump Inhibitors