Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2026-01-28 @ 6:08 AM
Study NCT ID:
NCT00547859
Status:
COMPLETED
Last Update Posted:
2008-11-26
First Post:
2007-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between Microcirculatory Flow Alterations and Tissue Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-11', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-11-25', 'studyFirstSubmitDate': '2007-10-22', 'studyFirstSubmitQcDate': '2007-10-22', 'lastUpdatePostDateStruct': {'date': '2008-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relation between MFI (by SDF) and capno', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Relevance of changes in flow and metabolism', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['microcirculation', 'cardiac surgery', 'metabolism', 'capnometry'], 'conditions': ['Cardiac Surgery']}, 'referencesModule': {'references': [{'pmid': '16280059', 'type': 'BACKGROUND', 'citation': 'Boerma EC, Mathura KR, van der Voort PH, Spronk PE, Ince C. Quantifying bedside-derived imaging of microcirculatory abnormalities in septic patients: a prospective validation study. Crit Care. 2005;9(6):R601-6. doi: 10.1186/cc3809. Epub 2005 Sep 22.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to correlate microcirculatory flow and rectal anaerobe cellular CO2 production in patients after cardiac surgery. The hypothesis is that such a correlation exists.', 'detailedDescription': 'Sidestream Darkfield imaging is used to determine rectal microcirculatory flow in patients after postoperative cardiac surgery. At the same time PCO2 gap is established by monitoring rectal CO2 (tonometry) and arterial CO2 After initial enrollment and first analysis we also includes a control group with equal inclusion criteria for sublingual SDF imaging.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'post cardiac surgery patients in the first two hours of ICU treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* cardiac surgery\n* informed consent\n* age \\> 18\n\nExclusion Criteria:\n\n* pregnancy\n* off pump procedure\n* rectal fecal contamination'}, 'identificationModule': {'nctId': 'NCT00547859', 'briefTitle': 'Relationship Between Microcirculatory Flow Alterations and Tissue Metabolism', 'organization': {'class': 'OTHER', 'fullName': 'Frisius Medisch Centrum'}, 'officialTitle': 'Correlation Between Microcirculatory Flow and Rectal Anaerobe Cellular CO2 Production in Patients After Cardiac Surgery', 'orgStudyIdInfo': {'id': 'TPO 503'}, 'secondaryIdInfos': [{'id': 'ABR 19609'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8901BR', 'city': 'Leeuwarden', 'state': 'PO Box 888', 'country': 'Netherlands', 'facility': 'Department of ICU', 'geoPoint': {'lat': 53.20271, 'lon': 5.80973}}], 'overallOfficials': [{'name': 'E.C. Boerma, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Frisius Medisch Centrum'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Frisius Medisch Centrum', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'EC Boerma', 'oldOrganization': 'Medical Center Leeuwarden'}}}}