Comparing Two Doses of IV Esomeprazole After Successful Endoscopic Therapy
- Conditions
- Peptic Ulcer Bleeding
- Interventions
- Device: heat probe or hemoclip
- Registration Number
- NCT04407832
- Lead Sponsor
- Changhua Christian Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- patients with peptic ulcer bleeding with active bleeding or nonbleeding visible (initial Hb<10, shock, or coffee grounds or blood in stomach)
- 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,
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description low dose PPI heat probe or hemoclip 40 mg esomeprazole IV for three days followed by esomeprazole 40 mg po daily for two months high dose PPI heat probe or hemoclip 40 mg esomeprazole IV every 6 hr for 3 days followed by 40 mg po daily for two months
- Primary Outcome Measures
Name Time Method further bleeding 14 days Number of participants with rebleeding within 14 days
- Secondary Outcome Measures
Name Time Method hospital stay 30 days hospital stay in day
need of blood transfusion 30 days number of participants need of blood transufion
surgical intervention 30 days number of participants need surgical intervention to manage bleeding
mortality 30 days number of participants death
Trial Locations
- Locations (1)
Division of Gastroenterology, TMUH
🇨🇳Taipei, Taiwan