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Trial record 2 of 3 for:    coffee enemas

Coffee Against Obstipation in Intensive Care Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 10, 2011
First Posted Date  ICMJE November 17, 2011
Last Update Posted Date November 17, 2011
Study Start Date  ICMJE November 2011
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2011)
Bowel movement rate [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2011)
  • time on mechanical ventilation [ Time Frame: participants will be followed for the duration of intensive care unit stay, an expected average of 3 weeks ]
  • time of stay on ICU [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks ]
  • lengths of hospitalisation [ Time Frame: an average of 5 weeks of hospital stay is expected ]
  • in hospital mortality [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks ]
  • long term mortality [ Time Frame: 6 months following discharge ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Coffee Against Obstipation in Intensive Care Treatment
Official Title  ICMJE Coffee Against Obstipation in Intensive Care Treatment
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Obstipation
Intervention  ICMJE
  • Dietary Supplement: coffee
    patients will receive a cup of coffee at room temperature orally twice daily
  • Dietary Supplement: coffee rectally
    patients receive an enema of two cups of coffee at room temperature once daily
    Other Name: Coffee
Study Arms  ICMJE
  • No Intervention: standard of care
    patients receive standard care
  • Experimental: Coffee orally
    patients will receive standard of care plus coffee orally
    Intervention: Dietary Supplement: coffee
  • Experimental: coffee rectally
    patients receive standard of care plus coffee rectally
    Intervention: Dietary Supplement: coffee rectally
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 14, 2011)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2014
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01473966
Other Study ID Numbers  ICMJE COFFEE
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christoph Eisenbach, University Hospital Heidelberg
Study Sponsor  ICMJE University Hospital Heidelberg
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christoph Eisenbach University of Heidelberg, Heidelberg, Germany
PRS Account University Hospital Heidelberg
Verification Date November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP