Coffee Against Obstipation in Intensive Care Treatment

NCT ID: NCT01473966

Last Updated: 2011-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2014-06-30

Brief Summary

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

Detailed Description

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Critically ill patients requiring ventilator support frequently suffer from obstipation. We hypothesize that coffee, administered either orally or rectally, might stimulate bowel movement.

Conditions

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Obstipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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standard of care

patients receive standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Coffee orally

patients will receive standard of care plus coffee orally

Group Type EXPERIMENTAL

coffee

Intervention Type DIETARY_SUPPLEMENT

patients will receive a cup of coffee at room temperature orally twice daily

coffee rectally

patients receive standard of care plus coffee rectally

Group Type EXPERIMENTAL

coffee rectally

Intervention Type DIETARY_SUPPLEMENT

patients receive an enema of two cups of coffee at room temperature once daily

Interventions

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coffee

patients will receive a cup of coffee at room temperature orally twice daily

Intervention Type DIETARY_SUPPLEMENT

coffee rectally

patients receive an enema of two cups of coffee at room temperature once daily

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Coffee

Eligibility 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Heidelberg

OTHER

Sponsor Role lead

Responsible Party

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Christoph Eisenbach

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christoph Eisenbach

Role: PRINCIPAL_INVESTIGATOR

University of Heidelberg, Heidelberg, Germany

Locations

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University hospital of Heidelberg

Heidelberg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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COFFEE

Identifier Type: -

Identifier Source: org_study_id