Comparison of High Dose Infusion and Low Dose Bolus Intravenous Omeprazole for Treatment of Bleeding Ulcer With Adherent Clot
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- rebleeding rate within 30 days after allocation
研究概览
简要总结
The investigators will include those patients with adherent clot on gastric or duodenal ulcers after endoscopic confirmation After receiving well explanation and giving written consent, they are enrolled and will be allocated to 2 groups randomly. Those in the first group will receive intravenous omeprazole 40 mg stat and then 40 mg q12h. Those in the second group will receive intravenous omeprazole 80 mg stat and then 8mg/hr infusion. The patients in both groups will receive intravenous omeprazole for 3 days and then oral esomeprazole qd for further treatment of peptic ulcer.
The investigators define rebleeding during admission and within 30 days as primary end points and define surgical intervention for ulcer bleeding, transfusion amount and hospitalization days after allocation as secondary end points.
详细描述
The investigators will include those patients with adherent clot on gastric or duodenal ulcers after endoscopic confirmation and exclusion of other possible bleeder. Adherent clot is defined that still stays on the ulcer after 200 ml normal saline irrigation (4 times of irrigation with 50 ml syringe). After receiving well explanation and giving written consent, they are enrolled and will be allocated to 2 groups randomly. Those in the first group will receive intravenous omeprazole 40 mg stat and then 40 mg q12h. Those in the second group will receive intravenous omeprazole 80 mg stat and then 8mg/hr infusion. The patients in both groups will receive intravenous omeprazole for 3 days and then oral esomeprazole qd for further treatment of peptic ulcer. The investigators will record the basic data of these patients including age, sex, use of NSAID or anit-coagulant, concomitant major diseases; clinical data including Hb, Plt, PT, the lowest systolic pressure before allocation and heart rate at the same time, shock status, transfusion amount before allocation; endoscopic findings including the location & size of ulcer, size of clot, existence of fresh blood in stomach or duodenum. The investigators will monitor the events of rebleeding during admission and within 30 days, surgery for ulcer bleeding and mortality within 30 days and record the amount of transfusion and hospitalization days after allocation. When rebleeding is suspected , those patient will receive endoscopic examination and appropriate therapy. Further treatment with surgical or angiographic intervention is decided by the attending physicians.These patients will be monitored during admission (2 weeks in average)and then followed up in GI outpatient clinics.
The investigators define rebleeding during admission and within 30 days as primary end points. Rebleeding is defined as the one of the clinical manifestations occurring 6 hours after allocation: 1.hematemesis or bloody stool 2. tarry stool and hemodynamic change (systolic pressure less than 90 mmHg, or heart more than 110 beats per minute ) 3. decrease of Hb more than 2g/dl within 24 hours after elevation of Hb to 10 g/dl with transfusion. The investigators define surgical intervention for ulcer bleeding, transfusion amount and hospitalization days after allocation as secondary end points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •We will include those patients with adherent clot, more than 5 mm, on gastric or duodenal ulcers after endoscopic confirmation and exclusion of other possible bleeder. Adherent clot is defined that still stays on the ulcer after 200 ml normal saline irrigation (4 times of irrigation with 50 ml syringe).
排除标准
- •ulcer with active bleeding, suspected malignant ulcer, patients with age less than 18 years old, or allergy to omeprazole
研究组 & 干预措施
1
receive high dose PPI treament with intravenous omeprazole 80 mg stat and then 8mg/hr infusion for 3 days
干预措施: omeprazole (Drug)
2
receive usual dose PPI treatment with ntravenous omeprazole 40 mg stat and then 40 mg q12h for 3 days
干预措施: omeprazole (Drug)
结局指标
主要结局
rebleeding rate within 30 days after allocation
时间窗: within 30 days after allocation
次要结局
- blood transfusion units needed within 30 days after allocation(within 30 days after allocation)
研究者
Tzong-Hsi Lee
M.D.
Far Eastern Memorial Hospital
