Intravenous Proton Pump Inhibitor for Peptic Ulcer Bleeding

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase 4 Study of Intravenous Proton Pump Inhibitor in Patients With Peptic Ulcer Bleeding After Successful Endoscopic Therapy- a Prospective Randomized Comparative Trial

Conditions
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Peptic Ulcer Hemorrhage

Intervention / Treatment
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* Drug: pantoprazole
* Drug: pantoprazole


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>pantoprazole 40mg/q6h IV infusion for three days | Drug: pantoprazole<br>* pantoprazole 40 mg/q6h IV infusion for three days<br>* Other names: pantoloc;|
| Active Comparator: 2<br>pantoprazole 8mg/h for three days | Drug: pantoprazole<br>* pantoprazole 8 mg/h IV infusion for three days<br>* Other names: pantoloc;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary end point was recurrent bleeding before discharge and within 14 days. |  | About one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| At day 14, volume of blood transfused, number of surgeries performed, and the mortality rates of the two groups are compared. |  | about one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shock, peptic ulcer bleeding, rebleeding