Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT06993467
Status:
COMPLETED
Last Update Posted:
2025-05-28
First Post:
2025-05-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Oxygen Delivery During Cardiopulmonary Bypass And Inflammatory Reaction After Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}], 'ancestors': [{'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 908}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-20', 'studyFirstSubmitDate': '2025-05-12', 'studyFirstSubmitQcDate': '2025-05-20', 'lastUpdatePostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SIRS', 'timeFrame': '12 hours after surgery', 'description': 'Systemic Inflammatory Reaction Syndrome (SIRS) as per the 1991 American College of Chest Physicians/Society of Critical Care Medicine criteria'}], 'secondaryOutcomes': [{'measure': 'Composite outcome', 'timeFrame': 'Up to 30 days', 'description': 'Composite outcome comprising death, TIA/stroke, renal replacement therapy, bleeding, mechanical circulatory support, or ICU stay \\>96 hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cardiopulmonary bypass', 'oxygen delivery', 'systemic inflammatory reaction syndrome', 'cardiac surgery'], 'conditions': ['Cardiopulmonary Bypass', 'Cardiac Surgery', 'Systemic Inflammatory Response Syndrome (SIRS)']}, 'descriptionModule': {'briefSummary': "Cardiac surgery, especially when involving cardiopulmonary bypass (CPB), has long been associated with a systemic inflammatory response that can lead to a range of complications, from mild symptoms to severe organ dysfunction, and mortality. The exact mechanisms behind this response remain a topic of extensive research, but it's clear that the body's reaction to the extracorporeal circulation, combined with surgical trauma, plays a significant role. Factors such as genomics, age, specific preoperative conditions, and the duration of operations have been associated with significant clinical responses.\n\nA pivotal insight into this response comes from recent genome-wide transcriptional analyses. Perioperative ischemia and ischemia-reperfusion injury (IRI) have been suggested as hub-nodes in a hierarchic structure evaluating the response to cardiac surgery. This suggests that IRI isn't just a side effect of the surgery but might be a central player in the body's inflammatory response. The role of perioperative ischemia and its potential as a significant contributor to the postoperative inflammatory response cannot be understated. This study aims to delve deeper into the role of oxygen delivery and its implications in the systemic inflammatory response post- cardiac surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult cardiac surgery patients undergoing elective cardiopulmonary bypass-assisted procedures', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (18-90 years)\n* Elective surgery\n* CPB-assisted\n\nExclusion Criteria:\n\n* Age \\< 18 or \\> 90 years\n* Infective endocarditis\n* Hypothermia during surgery (\\<34°C)\n* Emergency surgery'}, 'identificationModule': {'nctId': 'NCT06993467', 'acronym': 'OXYINFLAMM', 'briefTitle': 'Oxygen Delivery During Cardiopulmonary Bypass And Inflammatory Reaction After Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliero, Universitaria Ospedali Riuniti'}, 'officialTitle': 'Oxygen Delivery During Cardiopulmonary Bypass And Inflammatory Reaction After Cardiac Surgery', 'orgStudyIdInfo': {'id': 'OXY_INFLAMM.01'}}, 'contactsLocationsModule': {'locations': [{'city': 'Bari', 'state': 'Italia', 'country': 'Italy', 'facility': 'Anthea Hospital', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'city': 'Bari', 'state': 'Italia', 'country': 'Italy', 'facility': 'Santa Maria Hospital, GVM Care & Research', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliero, Universitaria Ospedali Riuniti', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Enrico Squiccimarro', 'investigatorAffiliation': 'Azienda Ospedaliero, Universitaria Ospedali Riuniti'}}}}