Clinical Effectiveness of Intravenous Esomeprazole Versus Pantoprazole in Preventing Peptic Ulcer Recurrent Bleeding: a Double-Blind Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 主要终点
- recurrent bleeding within 14 days of enrollment
研究概览
简要总结
The aim of this study is to compare the clinical effectiveness of intravenous esomeprazole and pantoprazole in preventing recurrent bleeding in the patients with high-risk bleeding peptic ulcers after successful standard endoscopic hemostasis.
详细描述
Endoscopic hemostasis and proton pump inhibitor (PPI) constitute the cornerstone in the management of peptic ulcer bleeding (PUB), which remains a prevalent disorder associated with substantial morbidity and mortality. Clinical effectiveness of PPI in the management of patients with PUB has been established by compelling evidence derived from a number of randomized trials. However, whether different PPIs are equally effective has not been investigated. Esomeprazole, the S-isomer of omeprazole, may achieve faster, more profound and steady acid suppression than other PPIs, but it remains undetermined whether the superiority of pharmacologic efficacy may be translated into advantages in clinical outcomes.
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, Care Provider)
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
- •aged more than 18 years
- •undergo emergent endoscopy within 24 hours of presentation
- •have peptic ulcers in the gastroesophageal junction, stomach, or duodenum
- •high-risk stigmata of peptic ulcers: Forrest classification IA~IIB
- •endoscopic hemostasis by thermocoagulation or clip placement
排除标准
- •pregnant or lactating
- •written informed consent not obtained
- •initial endoscopic hemostasis fail
- •bleeding tendency (platelet count < 50×109/L, prolonged prothrombin time for more than 3 seconds, or were taking anticoagulants)
- •PPI use within 14 days of enrollment
- •comorbid with severe hepatic or renal insufficiency (serum total bilirubin more than 5 mg/dL, serum creatinine more than 5 mg/dL, or under dialysis)
- •bleeding gastric cancers
研究组 & 干预措施
Esomeprazole
High-dose esomeprazole
干预措施: Esomeprazole (Drug)
Pantoprazole
High-dose pantoprazole
干预措施: Pantoprazole (Drug)
结局指标
主要结局
recurrent bleeding within 14 days of enrollment
时间窗: 14 days after enrollment
次要结局
- all-cause mortality(14 days after enrollment)
- length of hospital stay(probably one month after enrollment)
- Need for surgery(14 days after enrollment)
- Volume of blood transfusion(14 days after enrollment)
- bleeding-related mortality(14 days after enrollment)