Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2026-02-22 @ 5:22 PM
Study NCT ID:
NCT01813968
Status:
COMPLETED
Last Update Posted:
2023-12-15
First Post:
2013-03-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ischemic Postconditioning in Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D057775', 'term': 'Ischemic Postconditioning'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 209}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2018-06-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-11', 'studyFirstSubmitDate': '2013-03-13', 'studyFirstSubmitQcDate': '2013-03-14', 'lastUpdatePostDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in cardiac index between the groups during the first postoperative day', 'timeFrame': 'The first postoperative day: measurements at 2, 8 and 18 hrs postoperatively', 'description': 'Cardiac index is measured by a Swan-Ganz catheter inserted preoperatively'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ischemic postconditioning', 'Adult cardiac surgery', 'Aortic valve surgery', 'Swan-Ganz', 'Cardiac index'], 'conditions': ['Cardiac Surgery']}, 'descriptionModule': {'briefSummary': 'Ischemic postconditioning by repetitive cycles of reperfusion and ischemia has been proven both in animal models and in humans. This study aims to investigate the effect of ischemic postconditioning on postoperative hemodynamic function in a standard heart surgery patient population.', 'detailedDescription': 'Ischemic postconditioning is studied using cardiopulmonary bypass (CPB) and moderate hypothermia (32-34°C) in a patient population undergoing surgery of the aortic valve (repair/replacement ) or the ascending aorta. Postconditioning is applied by introducing reperfusion/ischemia via the cardioplegia line while the aorta is still cross-clamped thereby preventing the risk of additional neurological complications. All patients \\> 20 years eligible for aortic or aortic valve surgery and not affected by exclusion criteria, will be included.\n\nThe study is carried out as a randomised controlled multicenter study including 5-6 heart surgery centers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients undergoing elective surgery of the ascending aorta or the aortic valve\n\n\\-\n\nExclusion Criteria:\n\n* Coronary artery disease requiring bypass surgery\n* Tricuspid valve surgery\n* Mitral valve surgery\n* Atrial fibrillation (permanent or paroxysmal with or without concomitant ablation procedure)\n* Patients on per oral or parenteral steroid therapy (inhalational steroids are allowed)\n* Patients with autoimmune diseases\n* "Redo" operations\n* Active endocarditis (ongoing antibiotic therapy)\n* On the discretion of the operating surgeon or anaesthesiologist'}, 'identificationModule': {'nctId': 'NCT01813968', 'acronym': 'IPICS', 'briefTitle': 'Ischemic Postconditioning in Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Ischemic Postconditioning in Cardiac Surgery', 'orgStudyIdInfo': {'id': '2011/2613'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ischemic postconditioning', 'description': 'Ischemic postconditioning via the cardioplegia line starting with 2 min of reperfusion followed by 2 min of "ischemia" x 3', 'interventionNames': ['Procedure: Ischemic postconditioning']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard operating technique'}], 'interventions': [{'name': 'Ischemic postconditioning', 'type': 'PROCEDURE', 'armGroupLabels': ['Ischemic postconditioning']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0424', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Department of Cardiothoracic Surgery, Oslo University Hospital, Ullevål', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical University of Warsaw', 'class': 'OTHER'}, {'name': 'University Hospital of North Norway', 'class': 'OTHER'}, {'name': 'Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Mari-Liis Kaljusto', 'investigatorAffiliation': 'Oslo University Hospital'}}}}