Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2026-02-26 @ 4:30 PM
Study NCT ID:
NCT01748266
Status:
COMPLETED
Last Update Posted:
2012-12-12
First Post:
2012-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microcirculation of the Thenar Eminence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-11', 'studyFirstSubmitDate': '2012-12-07', 'studyFirstSubmitQcDate': '2012-12-11', 'lastUpdatePostDateStruct': {'date': '2012-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'microcirculatory reactivity', 'timeFrame': '10 minutes before anesthésia induction', 'description': 'Tissue oxygen saturation (StO2) measure by a tissue spectrometer with a 25 mm probe spacing placed on the thenar eminence'}], 'secondaryOutcomes': [{'measure': 'microcirculatory reactivity', 'timeFrame': 'during CPB (30 minutes after the start), and 2, 6, 12, 24 and 48 hours after the end of the CPB', 'description': 'Tissue oxygen saturation (StO2) measure by a tissue spectrometer with a 25 mm probe spacing placed on the thenar eminence'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['StO2', 'microcirculation', 'NIRS'], 'conditions': ['Elective Cardiac Surgery']}, 'descriptionModule': {'briefSummary': 'Microcirculatory disturbances following cardiac surgery with cardiopulmonary bypass (CPB) have been thought to be at the origin of organ dysfunction. Though, few studies correlated microvascular alterations with outcome. Investigators aimed at firstly describing microcirculation with near infra red spectroscopy (NIRS) and secondly correlating NIRS parameters with intensive care length of stay and organ dysfunction.', 'detailedDescription': '40 patients at high risk of post operative systemic inflammatory response syndrome after an elective cardiac surgery with CPB were included in this prospective observational study. Patients were studied during the first 48 postoperative hours. Microcirculation of the thenar eminence was analyzed by NIRS technology, through the StO2 and the resaturation slope after an ischemic challenge. Organ dysfunction was assessed with the SOFA score.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients at high risk of post operative systemic inflammatory response syndrome after an elective cardiac surgery with CPB', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* scheduled for an elective cardiac surgery at high risk of post operative systemic inflammatory response syndrome\n\nExclusion Criteria:\n\n* BMI\\>35'}, 'identificationModule': {'nctId': 'NCT01748266', 'briefTitle': 'Microcirculation of the Thenar Eminence', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Interest of the Measure of the StO2 to Estimate the Microcirculatory Disturbances Following Cardiac Surgery With Cardiopulmonary Bypass', 'orgStudyIdInfo': {'id': '1008018'}, 'secondaryIdInfos': [{'id': '2010-A00172-37', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'microcirculatory reactivity', 'description': 'Patients were studied during the first 48 postoperative hours. Microcirculation of the thenar eminence was analyzed by NIRS technology, through the StO2 and the resaturation slope after an ischemic challenge.', 'interventionNames': ['Other: microcirculatory reactivity']}], 'interventions': [{'name': 'microcirculatory reactivity', 'type': 'OTHER', 'description': 'Microcirculation of the thenar eminence was analyzed by NIRS technology, through the StO2 and the resaturation slope after an ischemic challenge.', 'armGroupLabels': ['microcirculatory reactivity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'Chu Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Jerome MOREL, Md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU SAINT-ETIENNE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}