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