Stress Ulcer Prophylaxis of Intravenous Esomeprazole in Chinese Seriously Ill Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stress Ulcer Prophylaxis

Intervention / Treatment
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* Drug: Esomeprazole
* Drug: Cimetidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Critically ill patients Requirement for mechanical ventilation At least one major risk factor for stress ulcer related bleeding Exclusion Criteria: History of gastric or oesophageal surgery Evidence of active GI bleeding Advanced renal disease Treatment with any Proton Pump Inhibitors

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Esomeprazole active treatment<br>iv esomeprazole 30 min intermittent infusions given for maximum 14 days | Drug: Esomeprazole<br>* iv esomeprazole 30 min intermittent infusions given for maximum 14 days<br>* Other names: Nexium;|
| Active Comparator: Cimetidine active treatment<br>iv cimetidine 30 min bolus infusion followed by iv cimetidine continuous infusion given for maximum 14 days | Drug: Cimetidine<br>* iv cimetidine 30 min bolus infusion followed by iv cimetidine continuous infusion given for maximum 14 days<br>* Other names: Tagamet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percent of Patients With Clinically Significant Upper-GI Bleeding During the Treatment Evaluation Phase | Criteria for a clinically significant upper GI bleeding as: Bright red blood per NG or OG tube that did not clear after NG or OG tube adjustment and 5 to 10 minutes of at least 100 ml lavage with room temperature normal saline-or, Persistent gastroccult- positive coffee ground material During IMP treatment Day 1-2: Persistent gastroccult- positive coffee ground material for at least eight consecutive hours that did not clear with at least 100 ml of lavage with room temperature normal saline. During IMP treatment Day 3-14: Persistent gastroccult- positive coffee ground material in at least three consecutive gastric aspirates within 2 to 4 hours (at least 60 ±20 minutes apart), that did not clear with at least 100 ml of lavage with room temperature normal saline. | 1-14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients With Any Overt Upper-GI Bleeding (Significant and Non-significant) During the Treatment Evaluation Phase | Criteria for a significant upper GI bleeding as described in primary outcome measure or, Criteria for a non-significant upper GI bleeding as: Bright red blood per NG or OG tube that clear after NG or OG tube adjustment and 5 to 10 minutes of lavage with room temperature normal saline or, Persistent gastroccult- positive coffee ground material During IMP treatment Day 1-2: Persistent gastroccult - positive coffee ground material for at less than eight consecutive hours or that clear with at least 100 ml of lavage with room temperature normal saline. During IMP treatment Day 3-14: Persistent gastroccult - positive coffee ground material in less than three consecutive gastric aspirates within 2 to 4 hours (at least 60±20 minutes apart), or that clear with at least 100 ml of lavage with room temperature normal saline or, Any clinical signs of hematemesis or melena or haematochezia judged (by the Investigator) to be from an upper GI source. | 1-14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SUP, Upper GI bleeding, Seriously ill patients