Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2025-12-27 @ 9:22 PM
Study NCT ID:
NCT05229159
Status:
COMPLETED
Last Update Posted:
2022-02-08
First Post:
2021-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bio Impedance Electrical Analysis to Predict Outcome After Cardiac Surgery
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': 220}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-27', 'studyFirstSubmitDate': '2021-11-22', 'studyFirstSubmitQcDate': '2022-01-27', 'lastUpdatePostDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the receiver operating characteristic curve to predict a composite criterion including in-hospital mortality or prolonged hospital length of stay.', 'timeFrame': 'at 6 months after the cardiac surgery', 'description': 'The phase angle\'s area under the receptor operative curve to predict a composite criteria evaluated at hospital discharge and combining:\n\n* In hospital mortality\n* Prolonged hospital length of stay, defined by an in hospital length of stay greater than the 75th percentile of length of stay in the study population"'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['phase angle', 'cardiac surgery', 'cardiopulmonary bypass', 'risk stratification', 'outcomes'], 'conditions': ['Post Operative Care After Cardiac Surgery With Cardio Pulmonary Bypass']}, 'descriptionModule': {'briefSummary': 'Phase angle determined by bioelectrical impedance analysis is a strong prognostic factor in several medical areas as clinical nutrition, nephrology, infectious disease, oncology. Inflammation, frailty status and fluid overload can lead to a phase angle decreased. Some studies support its use for risk stratification in intensive care unit and other in preoperative for cardiac surgery. The investigators would like to evaluate its relevance for risk stratification at intensive care unit admission in the context of postoperative cardiac surgery with cardiopulmonary bypass.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults patients admitted in intensive care unit for postoperative care after cardiac surgery with cardiopulmonary bypass.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age higher than 18\n* Cardiac surgery with cardiopulmonary bypass\n* Bioelectrical impedance analysis the day of the admission in intensive care unit\n\nExclusion Criteria:\n\n* Left ventricular assist device\n* Limitations des thérapeutiques actives en place pour le patient\n* Patient opposition to the use of his health data\n* Invalid bioelectrical impedance analysis\n* Advanced directives to withhold or withdraw life-sustaining treatment'}, 'identificationModule': {'nctId': 'NCT05229159', 'acronym': 'BiPOCS', 'briefTitle': 'Bio Impedance Electrical Analysis to Predict Outcome After Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Bio Impedance Electrical Analysis to Predict Outcome After Cardiac Surgery', 'orgStudyIdInfo': {'id': '456'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BiPOCS group', 'description': 'All patients of our centers admitted for postoperative care after cardiac surgery with cardiopulmonary bypass and receiving a bioelectrical impedance analysis at the admission.', 'interventionNames': ['Diagnostic Test: Bioelectrical impedance analysis']}], 'interventions': [{'name': 'Bioelectrical impedance analysis', 'type': 'DIAGNOSTIC_TEST', 'description': 'Segmental multi-frequency bioelectrical impedance analysis are carried out at all patient admitted to our ICU for postoperative care after cardiac surgery with cardiopulmonary bypass. Our objective is to evaluate the relevance of phase angle to predict mortality or a prolonged hospital length of stay. Phase angle is evaluated at ICU admission and will be compared to well-known prognostic scores computed in preoperative (EuroSCORE II) and at day one after surgery (SOFA, CASUS and SAPS II).', 'armGroupLabels': ['BiPOCS group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69500', 'city': 'Bron', 'state': 'Rhône', 'country': 'France', 'facility': 'Hôpital cardiologique Louis Pradel Groupe Hospitalier Est', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}