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

NCT00164866 | Completed Phase 4

• 1 other identifier: APPE
• Study Type: interventional
• Target: 638
• Locations: 1 country
• Sites: 1

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 patients'outcome and survival. To determine the therapeutic effect of high-dose PPI infusion in upper gastrointestinal bleeding from causes other than peptic ulcers.

Conditions

Peptic Ulcer

Keywords

Peptic ulcer; IVPPI prior endoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Interventions

Omeprazole DRUG

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with overt signs of upper GIB; fresh hematemesis and/or melena with or with circulatory compromise

You may not qualify if:

• Chronic aspirin user,
• Pregnancy,
• Age\<16,
• Allergy to PPI,
• No consent

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Endoscopy Center, Prince of Wales Hospital

Hong Kong SAR, China

Location

Related Publications (2)

• Tsoi KK, Lau JY, Sung JJ. Cost-effectiveness analysis of high-dose omeprazole infusion before endoscopy for patients with upper-GI bleeding. Gastrointest Endosc. 2008 Jun;67(7):1056-63. doi: 10.1016/j.gie.2007.11.056. Epub 2008 Apr 14.

  PMID: 18407271 DERIVED

• Lau JY, Leung WK, Wu JC, Chan FK, Wong VW, Chiu PW, Lee VW, Lee KK, Cheung FK, Siu P, Ng EK, Sung JJ. Omeprazole before endoscopy in patients with gastrointestinal bleeding. N Engl J Med. 2007 Apr 19;356(16):1631-40. doi: 10.1056/NEJMoa065703.

  PMID: 17442905 DERIVED

MeSH Terms

Conditions

Peptic Ulcer

Interventions

Omeprazole

Condition Hierarchy (Ancestors)

Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• James Y Lau, MD

  Endoscopy Center, Prince of Wales Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 14, 2005
• Study Start: February 1, 2004
• Study Completion: September 1, 2005
• Last Updated: June 6, 2007

Record last verified: 2007-06

Locations

CN (1)