Administration of High-Dose Intravenous Proton Pump Inhibitor for Upper Gastrointestinal Bleeding Prior to Endoscopy

Study Overview
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Brief Summary
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To evaluate if intravenous PPI infusion, when administered prior to endoscopy, hastens resolution of bleeding stigmata and thereby facilitates endoscopic examinations and reduces the need for endoscopic treatment. Clot stabilization may itself sustain control of bleeding before endoscopy. These may translate into improved patients'outcome and survival. To determine the therapeutic effect of high-dose PPI infusion in upper gastrointestinal bleeding from causes other than peptic ulcers.

Detailed Description
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A placebo-controlled randomised study is being proposed. We hypothesize that early administration of intravenous omeprazole infusion stabilizes clots overlying arteries and hastens resolution of bleeding stigmata in peptic ulcer, and facilitates subsequent endoscopic examinations and reduces the need for endoscopic treatment. This may translates into clinical benefits in those who receive early intravenous omeprazole. Consecutive patients with overt signs of upper gastrointestinal bleeding will be randomised to receive omeprazole or its equivalent placebo (80mg i.v. bolus followed by 8mg/hr) until next scheduled endoscopy. Patients with circulatory instability or fresh hematemesis will undergo endoscopic examinations urgently after initial stabilisation. The infusion will continue until endoscopic examination with or without therapy. Next scheduled endoscopy is performed within 24 hours from admission by experienced endoscopists with expertise in therapeutic endoscopy. At endoscopy, actively bleeding ulcers or ulcers with non-bleeding visible vessels are to be treated by endoscopic therapy. Omeprazole infusion 8mg/hr is to be continued for 72 hours after endoscopic hemostasis. Patients will be followed-up for 30 days from the time of admission or if patients stay longer than 30 days, the time to hospital discharge or death.

Official Title
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Administration of Intravenous Proton Pump Inhibitor Prior to Endoscopy [APPE] in Patients With Upper Gastrointestinal Bleeding; a Double-Blind Placebo-Controlled Randomised Study.

Conditions
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Peptic Ulcer

Intervention / Treatment
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* Drug: Omeprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with overt signs of upper GIB; fresh hematemesis and/or melena with or with circulatory compromise Exclusion Criteria: Chronic aspirin user, Pregnancy, Age<16, Allergy to PPI, No consent

Ages Eligible for Study
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Minimum Age: 16 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Omeprazole|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| early intranvenous infusion of a high-dose poton-pump inhibitor before endoscopy would have a therapeutic effect on bleeding ulcers, reduce the need for endoscopic therapy, and result in improved clinical outcomes. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Control of bleeding (absence of active bleeding) at the time of endoscopic procedure |  |  | 
| The prevalence of stigmata of bleeding at endoscopic examination |  |  | 
| 30-day survival |  |  | 
| Hospital stay |  |  | 
| Transfusion requirement |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peptic ulcer, IVPPI prior endoscopy