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Coffee Against Obstipation in Intensive Care Treatment

Primary Purpose

Obstipation

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
coffee
coffee rectally
Sponsored by
University Hospital Heidelberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obstipation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University hospital of Heidelberg

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

standard of care

Coffee orally

coffee rectally

Arm Description

patients receive standard care

patients will receive standard of care plus coffee orally

patients receive standard of care plus coffee rectally

Outcomes

Primary Outcome Measures

Bowel movement rate

Secondary Outcome Measures

time on mechanical ventilation
time of stay on ICU
lengths of hospitalisation
in hospital mortality
long term mortality

Full Information

First Posted
November 10, 2011
Last Updated
November 14, 2011
Sponsor
University Hospital Heidelberg
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1. Study Identification

Unique Protocol Identification Number
NCT01473966
Brief Title
Coffee Against Obstipation in Intensive Care Treatment
Official Title
Coffee Against Obstipation in Intensive Care Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Heidelberg

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstipation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
standard of care
Arm Type
No Intervention
Arm Description
patients receive standard care
Arm Title
Coffee orally
Arm Type
Experimental
Arm Description
patients will receive standard of care plus coffee orally
Arm Title
coffee rectally
Arm Type
Experimental
Arm Description
patients receive standard of care plus coffee rectally
Intervention Type
Dietary Supplement
Intervention Name(s)
coffee
Intervention Description
patients will receive a cup of coffee at room temperature orally twice daily
Intervention Type
Dietary Supplement
Intervention Name(s)
coffee rectally
Other Intervention Name(s)
Coffee
Intervention Description
patients receive an enema of two cups of coffee at room temperature once daily
Primary Outcome Measure Information:
Title
Bowel movement rate
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Secondary Outcome Measure Information:
Title
time on mechanical ventilation
Time Frame
participants will be followed for the duration of intensive care unit stay, an expected average of 3 weeks
Title
time of stay on ICU
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Title
lengths of hospitalisation
Time Frame
an average of 5 weeks of hospital stay is expected
Title
in hospital mortality
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Title
long term mortality
Time Frame
6 months following discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Eisenbach
Organizational Affiliation
University of Heidelberg, Heidelberg, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
University hospital of Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany

12. IPD Sharing Statement

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Coffee Against Obstipation in Intensive Care Treatment

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