Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT06840327
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-21
First Post:
2025-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of VARIation of OXYdo-reduction Potential in Cardiac Surgery on Post-operative Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Surgical residue from incision surgery planned for surgery without additional incision; catheter samples: peripheral venous blood, central venous blood, peripheral arterial blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-17', 'studyFirstSubmitDate': '2025-02-17', 'studyFirstSubmitQcDate': '2025-02-17', 'lastUpdatePostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Simplified Gravity Index', 'timeFrame': 'Day 7', 'description': 'severity score used in intensive care to assess the risk of in-hospital mortality. Score from 0 to 163 points (0 is the best possible state of health / 163 is the worst possible state of health )'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['extracorporeal circulation', 'cardiac surgery', 'biological markers', 'Redox balance', 'post-operative outcome'], 'conditions': ['Cardiac Surgery', 'Extracorporeal Circulation']}, 'descriptionModule': {'briefSummary': 'Observational, prospective, monocentric study conducted in the cardiac surgery department about biological markers to predict the short-term outcome of heart surgery patients.', 'detailedDescription': 'At present, there are no biological markers to predict the short-term outcome of heart surgery patients. Redox balance, determined by the interaction between oxidants and reducers in tissues, is an essential parameter in the regulation of cellular functions. Cardiac surgery with extracorporeal circulation (CEC) induces major disturbances in this balance. In preliminary work, it was observed that the redox potential (Eg) varied with the introduction of CEC, and a persistent imbalance appeared to correlate with post-operative complications. It is believed that Eg potential could be a new biomarker of the post-operative outcome of major surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing scheduled cardiac surgery under CEC for coronary bypass surgery with saphenous vein harvesting at Toulouse University Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients over 18 years of age Scheduled cardiac surgery patients undergoing bypass surgery with saphenous vein harvesting.\n\nPatients able to understand the protocol; Patients able to express non-opposition to participating in the study Patients affiliated to a social security system or equivalent.\n\nExclusion Criteria:\n\nEmergency surgery patients. Pregnant or breast-feeding women. Patients deprived of their freedom or under legal protective measures.'}, 'identificationModule': {'nctId': 'NCT06840327', 'acronym': 'VARIOXY', 'briefTitle': 'Impact of VARIation of OXYdo-reduction Potential in Cardiac Surgery on Post-operative Outcome', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Impact of VARIation of OXYdo-reduction Potential in Cardiac Surgery on Post-operative Outcome', 'orgStudyIdInfo': {'id': 'RC31/24/0523'}, 'secondaryIdInfos': [{'id': 'ID-RCB', 'type': 'OTHER', 'domain': '2025-A00118-41'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Scheduled cardiac surgery patients', 'description': 'Scheduled cardiac surgery patients undergoing bypass surgery with saphenous vein harvesting.', 'interventionNames': ['Other: Blood and tissue samples', 'Other: walking test']}], 'interventions': [{'name': 'Blood and tissue samples', 'type': 'OTHER', 'description': 'Blood samples will be taken from catheters placed for the purpose of surgery (arterial and venous catheters), or during routine venipunctures. (D-1 pre-op). Tissue samples will be taken from surgical waste generated by the surgery. They will therefore not require any additional incisions or surgical procedures.', 'armGroupLabels': ['Scheduled cardiac surgery patients']}, {'name': 'walking test', 'type': 'OTHER', 'description': 'The study includes a walking test between D5 and D7.', 'armGroupLabels': ['Scheduled cardiac surgery patients']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'François LABASTE, MD-PH', 'role': 'CONTACT', 'email': 'labaste.f@chu-toulouse.fr', 'phone': '05 61 32 28 22', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}