Coffee Against Obstipation in Intensive Care Treatment

Obstipation Clinical Trial

Official title:

Coffee Against Obstipation in Intensive Care Treatment

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01473966
• Other study ID #: COFFEE
• Status: Enrolling by invitation
• Phase: N/A
• First received: November 10, 2011
• Last updated: November 14, 2011
• Start date: November 2011
• Est. completion date: June 2014

Study information

• Verified date: November 2011
• Source: University Hospital Heidelberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obstipation

Intervention

Dietary Supplement:
• coffee
patients will receive a cup of coffee at room temperature orally twice daily
• coffee rectally
patients receive an enema of two cups of coffee at room temperature once daily

Locations

Country	Name	City	State
Germany	University hospital of Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Heidelberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bowel movement rate		participants will be followed for the duration of hospital stay, an expected average of 5 weeks	No
Secondary	time on mechanical ventilation		participants will be followed for the duration of intensive care unit stay, an expected average of 3 weeks	No
Secondary	time of stay on ICU		participants will be followed for the duration of hospital stay, an expected average of 5 weeks	No
Secondary	lengths of hospitalisation		an average of 5 weeks of hospital stay is expected	No
Secondary	in hospital mortality		participants will be followed for the duration of hospital stay, an expected average of 5 weeks	No
Secondary	long term mortality		6 months following discharge	No