Prospective Randomized Controlled Phase III Trial to Investigate the Efficacy of Magnesium Sulfate in the Prevention of Post-ERCP Pancreatitis.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 327
- 试验地点
- 1
- 主要终点
- reduction in the incidence of post-ERCP pancreatitis by 50 %
研究概览
简要总结
MagPEP is a multi-centre, randomized, phase III, double blind, placebo controlled, parallel group trial. It evaluates magnesium sulfate for the prevention of post-ERCP pancreatitis. Adult patients with a medical indication for ERCP are to be randomized (1:1 ratio) to receive either magnesium sulfate or placebo (NaCl 0,9%) 60 min before and 6 hours after ERCP.
详细描述
Title: prospective, randomized, placebo controlled, phase III trial to evaluate the efficacy of magnesium sulfate for the prevention of post-ERCP pancreatitis
Study drug: Magnesium sulfate
Indication: post-ERCP pancreatitis
Study design: multi-centre, randomized, phase III, double blind, placebo controlled, parallel group
Patient population: adult patients with a medical indication for ERCP
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •medical indication for ERCP
- •first ERCP in the Patient
- •signed informed consent forms for ERCP and MagPEP trial
排除标准
- •privious ERCP
- •hypersensitivity to study medication or similar substances
- •participation in another clinical trial during the last 4 weeks
- •addictive disorders
- •women who are pregnant or breastfeeding
- •unwillingness or inability to comply with study protocol
- •acute pancreatitis
- •renal insufficiency of stage 4 or higher
- •active hyperthyreosis
- •symptomatic bradycardia (<35/min)
- •known history of Myasthenia gravis
- •AV bock > first degree or other bradycardic disorders of conductivity
- •liver cirrhosis Child C
- •coagulation disorder
- •urinary stone diathesis (calcium magnesium ammonium phosphate stones)
- •patients who are not able to provide informed consent
- •intake of magnesium during the last 14 days
- •intake of calcium antagonists
研究组 & 干预措施
Magnesium
Patients receive 2 infusions of 500 ml NaCl 0,9%: the first one 60 min before ERCP and the second one 6 hours after ERCP.
With each infusion 10 ml magnesium sulfate (4930 mg magnesium sulfate = 20 mmol magnesium) are administered (total dose: 9860 mg magnesium sulfate).
干预措施: Magnesium Sulfate (Drug)
Placebo (NaCl 0,9%)
Patients receive 2 infusions of 500 ml NaCl 0,9%: the first one 60 min before ERCP and the second one 6 hours after ERCP.
To each infusion 10 ml NaCl 0.9% (Placebo) will be added .
干预措施: Placebo (NaCl 0,9%) (Drug)
结局指标
主要结局
reduction in the incidence of post-ERCP pancreatitis by 50 %
时间窗: 24 hours after ERCP
次要结局
- reduction in premature protease activation(during treatment period, assessed 24 h after ERCP)
- reduction in severity of post-ERCP pancreatitis(from 24 hours after ERCP onwards, assessed on day 30 after ERCP)
- reduction in 30-day morbidity(30 days after ERCP)
- reduction in intake of analgesics(during the first 24 hours after ERCP and, if a post-ERCP pancreatitis occurs, until discharge from hospital)
- duration of stay in hospital after ERCP(from end of ERCP to discharge from hospital; assessed on day 30 after ERCP)