NCT00428701已完成4 期
An Open-Label, Exploratory Trial to Assess Gastric Acid Control in Critically Ill Subjects Receiving Nexium I.V. (Esomeprazole Sodium) 40mg BID for up to 72 Hours
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 40
- 试验地点
- 5
- 主要终点
- The primary objective of the study is to assess gastric acid suppression by esomeprazole iv in critically ill subjects
研究概览
简要总结
This study is being done to see if Nexium I.V. can reduce and control stomach acid in mechanically ventilated, critically ill patients in an Intensive Care Unit setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Critically ill male or female subjects 18 years or older who have a baseline gastric aspirate pH less then or equal to 4
- •Subjects admitted to an ICU requiring mechanically ventilated
- •Subjects will have at least one additional stress ulcer risk factor
排除标准
- •Anticipated use of pre-pyloric enteral feeding after screening until the end of study
- •Physician estimated survival of less then 96 hours
- •Anticipation of major surgery within 96 hours of study enrollment
结局指标
主要结局
The primary objective of the study is to assess gastric acid suppression by esomeprazole iv in critically ill subjects
次要结局
- The secondary objective is to assess time to stable pH greater then or equal to 4 from start of drug
研究者
研究点 (5)
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