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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01473966 |
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Date of registration:
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10/11/2011 |
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Primary sponsor: |
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Public title:
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Coffee Against Obstipation in Intensive Care Treatment
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Scientific title:
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Coffee Against Obstipation in Intensive Care Treatment |
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Date of first enrolment:
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November 2011 |
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Target sample size:
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120 |
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Recruitment status: |
Enrolling by invitation |
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URL:
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http://clinicaltrials.gov/show/NCT01473966 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Countries of recruitment
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Germany
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Contacts
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Name:
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Christoph Eisenbach |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Heidelberg, Heidelberg, Germany |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Obstipation
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Intervention(s)
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Dietary Supplement: coffee
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Dietary Supplement: coffee rectally
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Primary Outcome(s)
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Bowel movement rate
[Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks]
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Secondary Outcome(s)
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in hospital mortality
[Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks]
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lengths of hospitalisation
[Time Frame: an average of 5 weeks of hospital stay is expected]
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long term mortality
[Time Frame: 6 months following discharge]
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time of stay on ICU
[Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks]
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time on mechanical ventilation
[Time Frame: participants will be followed for the duration of intensive care unit stay, an expected average of 3 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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