Coffee Against Obstipation in Intensive Care Treatment

Not Applicable

• Conditions: Obstipation
• Interventions: Dietary Supplement: coffee; Dietary Supplement: coffee rectally

• Registration Number: NCT01473966
• Lead Sponsor: University Hospital Heidelberg

Brief Summary

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

Detailed Description

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

Study Timeline

• Status Verified: 2011-11
• Study Start: 2011-11
• Study First Submitted: 2011-11-10
• Study First Submitted QC: 2011-11-14
• Last Update Submitted: 2011-11-14
• Study First Posted: 2011-11-17
• Last Update Posted: 2011-11-17
• Primary Completion: 2013-12
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coffee orally	coffee	patients will receive standard of care plus coffee orally
coffee rectally	coffee rectally	patients receive standard of care plus coffee rectally

Primary Outcome Measures

Name	Time	Method
Bowel movement rate	participants will be followed for the duration of hospital stay, an expected average of 5 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University hospital of Heidelberg; 🇩🇪 Heidelberg, Germany