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Coffee Against Obstipation in Intensive Care Treatment

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Christoph Eisenbach, University Hospital Heidelberg
ClinicalTrials.gov Identifier:
NCT01473966
First received: November 10, 2011
Last updated: November 14, 2011
Last verified: November 2011
History of Changes
  Purpose

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


Condition Intervention
Obstipation
 Dietary Supplement: coffee
Dietary Supplement: coffee rectally

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Coffee Against Obstipation in Intensive Care Treatment

Resource links provided by NLM:

MedlinePlus related topics: Bowel Movement
U.S. FDA Resources

Further study details as provided by University Hospital Heidelberg:

Primary Outcome Measures:
  • Bowel movement rate [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • time on mechanical ventilation [ Time Frame: participants will be followed for the duration of intensive care unit stay, an expected average of 3 weeks ] [ Designated as safety issue: No ]
  • time of stay on ICU [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks ] [ Designated as safety issue: No ]
  • lengths of hospitalisation [ Time Frame: an average of 5 weeks of hospital stay is expected ] [ Designated as safety issue: No ]
  • in hospital mortality [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks ] [ Designated as safety issue: No ]
  • long term mortality [ Time Frame: 6 months following discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: November 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: standard of care
patients receive standard care
Experimental: Coffee orally
patients will receive standard of care plus coffee orally
 Dietary Supplement: coffee
patients will receive a cup of coffee at room temperature orally twice daily
Other Name: Coffee
Experimental: coffee rectally
patients receive standard of care plus coffee rectally
 Dietary Supplement: coffee rectally
patients receive an enema of two cups of coffee at room temperature once daily
Other Name: Coffee

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01473966

Locations
Germany
University hospital of Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
University Hospital Heidelberg
Investigators
Principal Investigator: Christoph Eisenbach University of Heidelberg, Heidelberg, Germany
  More Information

No publications provided

Responsible Party: Christoph Eisenbach, Principal Investigator, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT01473966     History of Changes
Other Study ID Numbers: COFFEE
Study First Received: November 10, 2011
Last Updated: November 14, 2011
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013