Prospective Randomized Comparison of the Effect of Frequent Oral Dosing Versus Constant IV Infusion of Proton Pump Inhibitor on Intragastric pH in Patients With Bleeding Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Intragastric pH > 6
研究概览
简要总结
Patients with bleeding ulcers identified by endoscopy will be randomly assigned to receive an acid-blocking drug (called a proton pump inhibitor [PPI]) either by mouth every 3 hours for 24 hours or intravenously (IV) by constant infusion for 24 hours. A pH probe in the stomach will be used to determine intragastric pH (a measure of the acid production in the stomach) at baseline and during the 24 hours of therapy. The purpose of the study is to determine if the continuous intravenous administration of the drug provides better reduction of acid in the stomach than the oral administration.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting to hospital with overt upper GI bleeding and found to have an ulcer as the cause on endoscopy
排除标准
- •Previous gastric surgery
- •Active bleeding at end of endoscopy (despite hemostatic therapy)
- •Recent PPI or H2RA use
研究组 & 干预措施
1
Oral PPI
干预措施: Proton pump inhibitor (lansoprazole) (Drug)
2
Intravenous PPI
干预措施: Proton pump inhibitor (lansoprazole) (Drug)
结局指标
主要结局
Intragastric pH > 6
时间窗: 24 hours
次要结局
- Mean intragastric pH(24 hrs)
