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临床试验/NCT00374101
NCT00374101已完成3 期

Proton Pump Inhibitors in Conjunction to Endoscopic Therapy for Bleeding Peptic Ulcers: a Randomized Clinical Trial of High vs Standard Doses

Casa Sollievo della Sofferenza IRCCS10 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2005年1月1日最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
450
试验地点
10
主要终点
Rebleeding rates and surgical needs

研究概览

简要总结

High intravenous dosage of Proton Pump Inhibitors is not better than standard dosage in bleeding peptic ulcers successfully treated by endoscopic therapy

详细描述

The recent Canadian consensus conference on the management of patients with non-variceal upper gastrointestinal bleeding recommends a high regimen of PPIs, consisting in a dosage of 80-mg bolus followed by the 8 mg/H infusion, as being superior to the standard dosage (40 mg twice daily by bolus injection) in conjunction with some type of endoscopic therapy. However, by pooling data fromm studies comparing high doses of PPIs as continuous infusion versus regular doses as intermittent bolus, rebleeding, surgery, and mortality were not significantly different. As the previous conclusion became apparent in a meta-analytical evaluation of only 2 randomized clinical trials, more studies are needed on this topic.

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

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Consecutive patients admitted for upper gastrointestinal bleeding secondary to peptic ulcers that have been successfully treated with endoscopic therapy

排除标准

  • Variceal esophageal bleeding
  • Concurrent PPI use
  • Moribund patients

结局指标

主要结局

Rebleeding rates and surgical needs

次要结局

未报告次要终点

研究者

发起方
Casa Sollievo della Sofferenza IRCCS
申办方类型
Other

研究点 (10)

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