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
  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014