NCT02724150撤回4 期
Low Dose Against High Dose of Proton Pump Inhibitors in Treatment Acute Peptic Ulcer Bleeding
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
Evaluate the efficacy of Two different regimens of proton pump inhibitors High against Low in the management of acute peptic ulcer bleeding
详细描述
Evaluate the efficacy of Two different regimens of proton pump inhibitors in the management of acute peptic ulcer bleeding First: loading dose 80 mg then 8mg/h iv continuous infusion for 3 days Second Loading dose 80 mg the 40 mg every 12 h for 3 days
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •High risk ulcers defined according to the Forrest classification With respect to high-risk stigmata,
- •active bleeding was defined as a continuous blood spurting (Forrest IA)
- •oozing (Forrest IB) from the ulcer base.
- •A non-bleeding visible vessel at endoscopy was defined as a discrete protuberance at the ulcer base(Forrest IIA).
- •An adherent clot was one that was resistant to forceful irrigation or suction (Forrest IIB).
排除标准
- •ulcer was malignant
- •non ulcerative bleeding such as angiodysplasia , a Mallory-Weiss tear....
研究组 & 干预措施
Omeprazole High dose
Active Comparator
Omeprazole 80 mg loading dose,then 8mg/h IV continuous infusion for 3 days
干预措施: Omeprazole High dose (Drug)
Omeprazole Low Dose
Experimental
Omeprazole 80 mg loading dose IV then 40 mg two times per day IV for 3 days
干预措施: Omeprazole Low dose (Drug)
结局指标
主要结局
Mortality
时间窗: 1 month
次要结局
- Rebleeding(one month)
- Blood transfusions(one month)
- Length of hospital stay(one month)
- Surgery(one month)
研究者
研究点 (1)
Loading locations...
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