Peptic Ulcer Bleeding
Conditions
Keywords
hemostasis, heat probe, hemoclip, rebleeding
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.
Interventions
DEVICEheat probe or hemoclip
for hemostasis
Sponsors
Taipei Medical University Hospital
Dalin Tzu Chi General Hospital
Changhua Christian Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| further bleeding | 14 days | Number of participants with rebleeding within 14 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Taiwan
Outcome results
None listed