Effect of Intravenous Esomeprazole Versus Ranitidine on Gastric pH in Critically Ill Patients - a Prospective, Randomized, Double-Blind Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- the percentage of time with gastric pH > 4
研究概览
简要总结
H2-receptor antagonists are the gold standard for stress ulcer prophylaxis in critically ill patients. Various studies demonstrated superiority of proton pump inhibitors over H2-receptor antagonists in increasing gastric pH and in healing gastric acid-dependent diseases. It is unknown, whether proton pump inhibitors are more effective in increasing gastric pH than H2-receptor antagonists in critically ill patients requiring stress ulcer prophylaxis.
详细描述
Gastric pH is measured continuously for 72 hours with a pipolar microelectrode placed between 7 and 15cm below the lower esophageal sphincter.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •critically ill patients
- •indication for stress ulcer prophylaxis
- •gastric pH < 4
排除标准
- •gastrointestinal bleeding
- •gastric pH > 4
研究组 & 干预措施
1
patients with indication for stress ulcer prophylaxis and gastric pH < 4
干预措施: esomeprazole (Drug)
2
patients with indication for stress ulcer prophylaxis and gastric pH < 4
干预措施: ranitidine (Drug)
结局指标
主要结局
the percentage of time with gastric pH > 4
时间窗: 72 hours
次要结局
- median gastric pH(72 hours)
- incidence of gastrointestinal bleeding(72 hours)
- incidence of ventilator associated pneumonia(ICU stay)
- the percentage of time with an gastric pH > 5(72 hours)