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

Peptic Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00164866
• Other study ID #: APPE
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: June 5, 2007
• Start date: February 2004
• Est. completion date: September 2005

Study information

• Verified date: June 2007
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 638
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Peptic Ulcer

Intervention

Drug:
• Omeprazole

Locations

Country	Name	City	State
China	Endoscopy Center, Prince of Wales Hospital	Hong Kong SAR

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Control of bleeding (absence of active bleeding) at the time of endoscopic procedure
Secondary	The prevalence of stigmata of bleeding at endoscopic examination
Secondary	30-day survival
Secondary	Hospital stay
Secondary	Transfusion requirement