Intravenous Proton Pump Inhibitor for Peptic Ulcer Bleeding

Phase 4

Completed

• Conditions: Peptic Ulcer Hemorrhage
• Interventions: Drug: pantoprazole

• Registration Number: NCT00731601
• Lead Sponsor: Lotung Poh-Ai Hospital

Brief Summary

A large dose of PPI is effective in preventing peptic ulcer rebleeding. The investigators hypothesize that 40 mg/q6h pantoloc is equivalent to 8mg/h pantoloc in preventing rebleeding.

Detailed Description

A bleeding peptic ulcer remains a serious medical problem with significant morbidity and mortality. Endoscopic therapy significantly reduces further bleeding, surgery, and mortality in patients with bleeding peptic ulcers and is now recommended as the first hemostatic modality for these patients.

In the past few years, adjuvant use of a high-dose proton pump inhibitor (PPI) after endoscopic therapy has been endorsed in some studies, two consensus statements and two meta-analysis. In our previous experience, we used omeprazole 160 mg /day infusion instead of 8 mg/h in these patients and obtained a good result .

The objectives of this study are to assess the outcomes of two different regimens of high dose of intravenous pantoprazole after endoscopic therapy in patients with peptic ulcer bleeding.

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-08-07
• Study First Submitted QC: 2008-08-08
• Study First Posted: 2008-08-11
• Primary Completion: 2009-03
• Status Verified: 2009-04
• Study Completion: 2009-04
• Last Update Submitted: 2009-04-06
• Last Update Posted: 2009-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patients were accepted for endoscopic therapy if a peptic ulcer with active bleeding, a non-bleeding visible vessel (NBVV) or an adherent blood clot at the ulcer base was observed within 24 hours of hospital admission.

Exclusion Criteria

• If patients were pregnant
• Did not obtain initial hemostasis with endoscopic injection of epinephrine
• Did not give written informed consent
• Had bleeding tendency (platelet count < 50×109/L, serum prothrombin < 30% of normal, or were taking anticoagulants), uremia.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	pantoprazole	pantoprazole 40mg/q6h IV infusion for three days
2	pantoprazole	pantoprazole 8mg/h for three days

Primary Outcome Measures

Name	Time	Method
The primary end point was recurrent bleeding before discharge and within 14 days.	About one year

Secondary Outcome Measures

Name	Time	Method
At day 14, volume of blood transfused, number of surgeries performed, and the mortality rates of the two groups are compared.	about one year

Trial Locations

Locations (1)

Lotung Poh-Ai hospital; 🇨🇳 Yilan, Taiwan