Efficacy of Prucalopride in Critically Ill Patients With Paralytic Ileus; a Pilot Randomized Double-blind Controlled Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Change of maximum bowel diameter from baseline at 120 hours
研究概览
简要总结
Paralytic ileus is a common intestinal dysfunction in critically ill patients. There are still no established the effective medications except correcting the primary causes and prokinetics trial which limited in efficacy and potential adverse events.
详细描述
Prucalopride, a highly selective 5-HT4 receptor agonist, accelerates gastrointestinal transit which may reduce severity of ileus. Furthermore, there is no report of serious cardiac and neurological side effects. We aim to evaluate the efficacy of prucalopride as a prokinetic of choice on paralytic ileus in critically 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
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The intervention was blinded to patients, nurse, investigators, and radiologist
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Prucalopride
Prucalopride (Trade name: Resolor) 2 mg oral or tube feeding once daily 5 consecutive days Decrease dose to 1 mg once daily in patient with end stage kidney disease or Cirrhosis Child Pugh C
干预措施: Prucalopride (Drug)
Placebo
Placebo tablet to mimic Prucalopride made by starch
干预措施: Placebo (Drug)
结局指标
主要结局
Change of maximum bowel diameter from baseline at 120 hours
时间窗: after first dose intervention to next 120 hours
measure on plain abdominal radiography by blinded radiologist
Change of maximum bowel diameter from baseline at 24 hours
时间窗: after first dose intervention to next 24 hours
measure on plain abdominal radiography by blinded radiologist
Change of maximum bowel diameter from baseline at 96 hours
时间窗: after first dose intervention to next 96 hours
measure on plain abdominal radiography by blinded radiologist
Change of maximum bowel diameter from baseline at 48 hours
时间窗: after first dose intervention to next 48 hours
measure on plain abdominal radiography by blinded radiologist
Change of maximum bowel diameter from baseline at 72 hours
时间窗: after first dose intervention to next 72 hours
measure on plain abdominal radiography by blinded radiologist
次要结局
- change of abdominal circumference from baseline at 96 hours(after first dose intervention to next 96 hours)
- change of abdominal circumference from baseline at 24 hours(after first dose intervention to next 24 hours)
- change of abdominal circumference from baseline at 72 hours(after first dose intervention to next 72 hours)
- change of abdominal circumference from baseline at 120 hours(after first dose intervention to next 120 hours)
- change of abdominal circumference from baseline at 48 hours(after first dose intervention to next 48 hours)
研究者
Panu Wetwittayakhlang
Principal investigator
Prince of Songkla University