Comparing Two Doses of IV Esomeprazole After Successful Endoscopic Therapy

Study Overview
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Brief Summary
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The investigators used two different doses of esomeprazole (40 mg IV q.d. and 40 mg IV q6h for three days followed by esomeprazole 40 mg q.d. orally in two groups) after successful endoscopic therapy with heat probe therapy or hemoclip placement. The goal of this study is to assess the outcomes of two different regimens of low vs. high dose of intravenous esomeprazole after endoscopic therapy in patients with peptic ulcer bleeding.

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 receiving intravenous Proton Pump Inhibitor (PPI）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, including two consensus statements and two meta-analysis. To sustain a high intragastric pH, a high dose of omeprazole has been used in previous studies concerning high-risk peptic ulcer bleeding. However, in one recent published metaanalysis found that low dose PPI may be as effective as high dose PPI in preventing further bleeding in high-risk patients. Therefore, one double blind study is needed clarify this puzzle. We used two different doses of esomeprazole (40 mg IV q.d. and 40 mg IV q6h for three days followed by esomeprazole 40 mg q.d. orally in two groups) after successful endoscopic therapy with heat probe therapy or hemoclip placement. The goal of this study is to assess the outcomes of two different regimens of low vs. high dose of intravenous esomeprazole after endoscopic therapy in patients with peptic ulcer bleeding.

Official Title
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A Double Blind Study Comparing Low Dose and High Dose IV Esomeprazole After Successful Endoscopic Therapy in Patients With Peptic Ulcer Bleeding

Conditions
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Peptic Ulcer Bleeding

Intervention / Treatment
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* Device: heat probe or hemoclip
* Device: heat probe or hemoclip


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with peptic ulcer bleeding with active bleeding or nonbleeding visible (initial Hb<10, shock, or coffee grounds or blood in stomach) Exclusion Criteria: age >90y/o pregnant woman allergic to esomeprazole unwilling to enter this study bleeding tendency severe co-morbid illness, including cancer, hepatic failure, renal failure,

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: low dose PPI<br>40 mg esomeprazole IV for three days followed by esomeprazole 40 mg po daily for two months | Device: heat probe or hemoclip<br>* for hemostasis<br>* Other names: Olympus co.;|
| Active Comparator: high dose PPI<br>40 mg esomeprazole IV every 6 hr for 3 days followed by 40 mg po daily for two months | Device: heat probe or hemoclip<br>* for hemostasis<br>* Other names: Olympus co.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| further bleeding | Number of participants with rebleeding within 14 days | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospital stay | hospital stay in day | 30 days | 
| need of blood transfusion | number of participants need of blood transufion | 30 days | 
| surgical intervention | number of participants need surgical intervention to manage bleeding | 30 days | 
| mortality | number of participants death | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemostasis, heat probe, hemoclip, rebleeding