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Coffee Against Obstipation in Intensive Care Treatment

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ClinicalTrials.gov Identifier: NCT01473966
Recruitment Status : Unknown
Verified November 2011 by Christoph Eisenbach, University Hospital Heidelberg.
Recruitment status was:  Enrolling by invitation
First Posted : November 17, 2011
Last Update Posted : November 17, 2011
Sponsor:
Information provided by (Responsible Party):
Christoph Eisenbach, University Hospital Heidelberg

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

Condition or disease Intervention/treatment Phase
Obstipation Dietary Supplement: coffee Dietary Supplement: coffee rectally Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Coffee Against Obstipation in Intensive Care Treatment
Study Start Date : November 2011
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : June 2014

Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. Bowel movement rate [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks ]

Secondary Outcome Measures :
  1. time on mechanical ventilation [ Time Frame: participants will be followed for the duration of intensive care unit stay, an expected average of 3 weeks ]
  2. time of stay on ICU [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks ]
  3. lengths of hospitalisation [ Time Frame: an average of 5 weeks of hospital stay is expected ]
  4. in hospital mortality [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks ]
  5. long term mortality [ Time Frame: 6 months following discharge ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Christoph Eisenbach, Principal Investigator, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT01473966     History of Changes
Other Study ID Numbers: COFFEE
First Posted: November 17, 2011    Key Record Dates
Last Update Posted: November 17, 2011
Last Verified: November 2011

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