Optimal Dose of Omeprazole After Endoscopic Treatment of Bleeding Peptic Ulcers
Intravenous Infusion of High Dose Omeprazole Versus Regular Dose Omeprazole on Recurrent Bleeding After Endoscopic Treatment of Bleeding Peptic Ulcers
研究概览
详细说明
Introduction
Peptic ulcer bleeding (PUB) is a common and life threatening condition. Intravenous infusion of high dose omeprazole (80mg as bolus followed by 8 mg/hr for 72 hours ie 652 mg/72 hrs) after endoscopic therapy resulted in greater reductions of re-bleeding than did placebo. Thus the above regime became our departmental protocol. However, there is some evidence that both high dose and a regular dose of omeprazole (40mg once a day followed by a saline infusion ie 120mg/72 hrs) would be equally effective. We calculated that high dose regimen is about S$ 500 more expensive. The aim of our study is to determine the equivalence of both regimes in preventing re-bleeding rate (primary end-point), surgery and mortality in PUB patients.
Study design This is a single institution prospective randomized double-blind study. All patient with PUB (Forrest classification I, IIa and IIb: spurting or oozing bleeding, visible vessels and clot) had endoscopic treatments (adrenaline injection and/or heater probe). After successful endoscopic hemostasis, patients are randomized to receive a high or regular dose of omeprazole infusion. After 72 hours, both groups of patients are given oral omeprazole 40mg daily for 4 weeks. All patients are evaluated at the clinic at the end of 4 weeks. The primary end-point is rebleeding. Other secondary endpoints measured are surgery, duration of hospital stay and death.
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Outram Road
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Outram Road, Singapore、Outram Road、新加坡、169608
- Singapore General Hospital
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Singapore、Outram Road、新加坡、169608
- Singapore General Hospital
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Outram road
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Outram Road, Singapore、Outram road、新加坡、169608
- Department of Surgery, Singapore General Hospital
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Singapore、Outram road、新加坡、169608
- Department of Surgery, Singapore General Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Above 21 year old
- OGD done within 48 hrs of admission
- No recent upper GIT surgery past one month
- Forrest Type I, IIa & IIb ulcer (Type Ia: Spurting, Ib:Oozing, IIa: Visible vessel, IIb: Clot)
- Non-malignant ulcer
- Informed consent taken
Exclusion Criteria:
- Impaired hepatic function
- Pregnancy
- Lactation
- Concomitant medication (warfarin, diazepam, phenytoin, chlarithromycin, cimetidine and digoxin)
- Underlying malignancy
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:单组作业
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:2
regular dose versus high dose
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intravenous 80mg bolus followed by 8mg / hr for 3 days
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Re-bleeding rate after endoscopic treatment of bleeding peptic ulcers
大体时间:30 days after endoscopic therapy
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30 days after endoscopic therapy
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次要结果测量
结果测量 |
大体时间 |
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Surgery, Death and Length of hospital stay
大体时间:30 days after endoscopic thearpy
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30 days after endoscopic thearpy
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合作者和调查者
调查人员
- 首席研究员:Weng Hoong Chan, MBBS, FRCS、Singapore General Hospital
- 首席研究员:Weng Hoong Chan, MBBS, FRCS、Department of Surgery, Singapore General Hospital
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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