Effect of Intravenous Esomeprazole Versus Cimetidine in Prevention of Stress Ulcer Prophylaxis in Chinese Seriously Ill Patients - a Randomized, Double-blind, Parallel-group Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 343
- 试验地点
- 1
- 主要终点
- The Percent of Patients With Clinically Significant Upper-GI Bleeding During the Treatment Evaluation Phase
研究概览
简要总结
The efficacy of esomeprazole will be compared versus cimetidine (a drug that previously demonstrated prevention of bleeding events) during treatment period in proportion of patients for the prevention of upper GI bleeding.
详细描述
Stress related upper Gastrointestinal (GI) bleedings are important events associated with morbidity and mortality among seriously ill patients. Data from the literature suggest that stress ulcer prevention with effective acid suppressive treatment can reduce bleeding events and is thus an important therapy in high-risk patients. Esomeprazole has the potential to reduce gastric acidity for prolonged periods of time adequate for both preventing mucosal damage and facilitating coagulation. This study is to reveal whether intravenous (iv) esomeprazole is effective in preventing upper gastrointestinal bleeding and if it is tolerated by Chinese seriously ill patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Critically ill patients
- •Requirement for mechanical ventilation
- •At least one major risk factor for stress ulcer related bleeding
排除标准
- •History of gastric or oesophageal surgery
- •Evidence of active GI bleeding
- •Advanced renal disease
- •Treatment with any Proton Pump Inhibitors
研究组 & 干预措施
Esomeprazole active treatment
iv esomeprazole 30 min intermittent infusions given for maximum 14 days
干预措施: Esomeprazole (Drug)
Cimetidine active treatment
iv cimetidine 30 min bolus infusion followed by iv cimetidine continuous infusion given for maximum 14 days
干预措施: Cimetidine (Drug)
结局指标
主要结局
The Percent of Patients With Clinically Significant Upper-GI Bleeding During the Treatment Evaluation Phase
时间窗: 1-14 days
Criteria for a clinically significant upper GI bleeding as: 1. Bright red blood per NG or OG tube that did not clear after NG or OG tube adjustment and 5 to 10 minutes of at least 100 ml lavage with room temperature normal saline-or, 2. Persistent gastroccult- positive coffee ground material During IMP treatment Day 1-2: Persistent gastroccult- positive coffee ground material for at least eight consecutive hours that did not clear with at least 100 ml of lavage with room temperature normal saline. During IMP treatment Day 3-14: Persistent gastroccult- positive coffee ground material in at least three consecutive gastric aspirates within 2 to 4 hours (at least 60 ±20 minutes apart), that did not clear with at least 100 ml of lavage with room temperature normal saline.
次要结局
- Proportion of Patients With Any Overt Upper-GI Bleeding (Significant and Non-significant) During the Treatment Evaluation Phase(1-14 days)