MedPath

High Versus Standard Dose of Proton Pump Inhibitors (PPIs) in Peptic Ulcer Bleeding

Phase 3
Completed
Conditions
Peptic Ulcers
Upper Gastrointestinal Bleeding
Registration Number
NCT00374101
Lead Sponsor
Casa Sollievo della Sofferenza IRCCS
Brief Summary

High intravenous dosage of Proton Pump Inhibitors is not better than standard dosage in bleeding peptic ulcers successfully treated by endoscopic therapy

Detailed Description

The recent Canadian consensus conference on the management of patients with non-variceal upper gastrointestinal bleeding recommends a high regimen of PPIs, consisting in a dosage of 80-mg bolus followed by the 8 mg/H infusion, as being superior to the standard dosage (40 mg twice daily by bolus injection) in conjunction with some type of endoscopic therapy. However, by pooling data fromm studies comparing high doses of PPIs as continuous infusion versus regular doses as intermittent bolus, rebleeding, surgery, and mortality were not significantly different. As the previous conclusion became apparent in a meta-analytical evaluation of only 2 randomized clinical trials, more studies are needed on this topic.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
450
Inclusion Criteria
  • Consecutive patients admitted for upper gastrointestinal bleeding secondary to peptic ulcers that have been successfully treated with endoscopic therapy
Exclusion Criteria
  • Variceal esophageal bleeding
  • Concurrent PPI use
  • Moribund patients

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Rebleeding rates and surgical needs
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (4)

Division of Internal Medicine

🇮🇹

Polla, Salerno, Italy

Division of Gastroenterology

🇮🇹

Vasto, Italy

DIvision of Gastroenterology

🇮🇹

Como, Italy

DIvision of Internal Medicine

🇮🇹

Ivrea, Italy

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