Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-27 @ 4:13 PM
Study NCT ID:
NCT01473966
Status:
UNKNOWN
Last Update Posted:
2011-11-17
First Post:
2011-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coffee Against Obstipation in Intensive Care Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003069', 'term': 'Coffee'}], 'ancestors': [{'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-11-14', 'studyFirstSubmitDate': '2011-11-10', 'studyFirstSubmitQcDate': '2011-11-14', 'lastUpdatePostDateStruct': {'date': '2011-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bowel movement rate', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 5 weeks'}], 'secondaryOutcomes': [{'measure': 'time on mechanical ventilation', 'timeFrame': 'participants will be followed for the duration of intensive care unit stay, an expected average of 3 weeks'}, {'measure': 'time of stay on ICU', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 5 weeks'}, {'measure': 'lengths of hospitalisation', 'timeFrame': 'an average of 5 weeks of hospital stay is expected'}, {'measure': 'in hospital mortality', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 5 weeks'}, {'measure': 'long term mortality', 'timeFrame': '6 months following discharge'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obstipation']}, 'descriptionModule': {'briefSummary': 'Coffee might stimulate bowel movement and thus overcome obstipation in intensive care unit (ICU) patients.', 'detailedDescription': 'Critically ill patients requiring ventilator support frequently suffer from obstipation. We hypothesize that coffee, administered either orally or rectally, might stimulate bowel movement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* admission to the medical intensive care unit of the Dept. of Gastroenterology at the university hospital heidelberg\n* requires ventilator support for an anticipated more than 72 hours\n* age older than 18 years\n\nExclusion Criteria:\n\n* pregnancy\n* known allergy to coffee\n* mechanical ileus\n* presence of enterostoma'}, 'identificationModule': {'nctId': 'NCT01473966', 'briefTitle': 'Coffee Against Obstipation in Intensive Care Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Heidelberg'}, 'officialTitle': 'Coffee Against Obstipation in Intensive Care Treatment', 'orgStudyIdInfo': {'id': 'COFFEE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'standard of care', 'description': 'patients receive standard care'}, {'type': 'EXPERIMENTAL', 'label': 'Coffee orally', 'description': 'patients will receive standard of care plus coffee orally', 'interventionNames': ['Dietary Supplement: coffee']}, {'type': 'EXPERIMENTAL', 'label': 'coffee rectally', 'description': 'patients receive standard of care plus coffee rectally', 'interventionNames': ['Dietary Supplement: coffee rectally']}], 'interventions': [{'name': 'coffee', 'type': 'DIETARY_SUPPLEMENT', 'description': 'patients will receive a cup of coffee at room temperature orally twice daily', 'armGroupLabels': ['Coffee orally']}, {'name': 'coffee rectally', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Coffee'], 'description': 'patients receive an enema of two cups of coffee at room temperature once daily', 'armGroupLabels': ['coffee rectally']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'University hospital of Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'overallOfficials': [{'name': 'Christoph Eisenbach', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Heidelberg, Heidelberg, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Heidelberg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Christoph Eisenbach', 'investigatorAffiliation': 'University Hospital Heidelberg'}}}}