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临床试验/NCT01473966
NCT01473966Unknown不适用

Coffee Against Obstipation in Intensive Care Treatment

University Hospital Heidelberg1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2011年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
120
试验地点
1
主要终点
Bowel movement rate

研究概览

简要总结

Coffee might stimulate bowel movement and thus overcome obstipation in intensive care unit (ICU) patients.

详细描述

Critically ill patients requiring ventilator support frequently suffer from obstipation. We hypothesize that coffee, administered either orally or rectally, might stimulate bowel movement.

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
None

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

  • •admission to the medical intensive care unit of the Dept. of Gastroenterology at the university hospital heidelberg
  • •requires ventilator support for an anticipated more than 72 hours
  • •age older than 18 years

排除标准

  • •pregnancy
  • •known allergy to coffee
  • •mechanical ileus
  • •presence of enterostoma

研究组 & 干预措施

standard of care

No Intervention

patients receive standard care

coffee rectally

Experimental

patients receive standard of care plus coffee rectally

干预措施: coffee rectally (Dietary Supplement)

Coffee orally

Experimental

patients will receive standard of care plus coffee orally

干预措施: coffee (Dietary Supplement)

结局指标

主要结局

Bowel movement rate

时间窗: participants will be followed for the duration of hospital stay, an expected average of 5 weeks

次要结局

  • long term mortality(6 months following discharge)
  • time on mechanical ventilation(participants will be followed for the duration of intensive care unit stay, an expected average of 3 weeks)
  • time of stay on ICU(participants will be followed for the duration of hospital stay, an expected average of 5 weeks)
  • lengths of hospitalisation(an average of 5 weeks of hospital stay is expected)
  • in hospital mortality(participants will be followed for the duration of hospital stay, an expected average of 5 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christoph Eisenbach

Principal Investigator

University Hospital Heidelberg

研究点 (1)

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