Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00164866
Status:
COMPLETED
Last Update Posted:
2007-06-06
First Post:
2005-09-12
Brief Title:
Administration of High-Dose Intravenous Proton Pump Inhibitor for Upper Gastrointestinal Bleeding Prior to Endoscopy
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 patientsoutcome and survival
To determine the therapeutic effect of high-dose PPI infusion in upper gastrointestinal bleeding from causes other than peptic ulcers
To determine the therapeutic effect of high-dose PPI infusion in upper gastrointestinal bleeding from causes other than peptic ulcers
Detailed 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 iv bolus followed by 8mghr 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 8mghr 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
Consecutive patients with overt signs of upper gastrointestinal bleeding will be randomised to receive omeprazole or its equivalent placebo 80mg iv bolus followed by 8mghr 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 8mghr 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None