Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 12:26 AM
Study NCT ID:
NCT04058860
Status:
COMPLETED
Last Update Posted:
2022-07-25
First Post:
2019-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Microcirculation During Extracorporeal Circulation in Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients undergoing open heart surgery with minimal invasive extracorporeal circulation (MiECC) according to accepted indications'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-22', 'studyFirstSubmitDate': '2019-08-12', 'studyFirstSubmitQcDate': '2019-08-13', 'lastUpdatePostDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of microcirculation', 'timeFrame': 'During surgery, from induction of anesthesia to weaning of extracorporeal circulation', 'description': 'Correlation of NIRS values with tissue microvascular activity'}], 'secondaryOutcomes': [{'measure': 'Global perfusion', 'timeFrame': 'During surgery, from induction of anesthesia to weaning of extracorporeal circulation', 'description': 'Global perfusion using cerebral NIRS during extracorporeal circulation'}, {'measure': 'Cerebral autoregulation', 'timeFrame': 'During surgery, from induction of anesthesia to weaning of extracorporeal circulation', 'description': 'Calculation of cerebral oximetry index (COx)'}, {'measure': 'Goal-directed perfusion', 'timeFrame': 'During surgery, from induction of anesthesia to weaning of extracorporeal circulation', 'description': 'Correlation of goal-directed perfusion with microvascular capillary density during extracorporeal circulation'}, {'measure': 'Somatic perfusion', 'timeFrame': 'During surgery, from induction of anesthesia to weaning of extracorporeal circulation', 'description': 'Peripheral tissue oxygenation as measured with somatic NIRS'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Microcirculation', 'Cardiac Surgery'], 'conditions': ['Heart Diseases']}, 'referencesModule': {'references': [{'pmid': '28692337', 'type': 'BACKGROUND', 'citation': 'Anastasiadis K, Antonitsis P, Deliopoulos A, Argiriadou H. A multidisciplinary perioperative strategy for attaining "more physiologic" cardiac surgery. Perfusion. 2017 Sep;32(6):446-453. doi: 10.1177/0267659117700488. Epub 2017 Mar 10.'}, {'pmid': '27013118', 'type': 'BACKGROUND', 'citation': 'Anastasiadis K, Antonitsis P, Ranucci M, Murkin J. Minimally Invasive Extracorporeal Circulation (MiECC): Towards a More Physiologic Perfusion. J Cardiothorac Vasc Anesth. 2016 Apr;30(2):280-1. doi: 10.1053/j.jvca.2016.01.018. Epub 2016 Jan 13. No abstract available.'}, {'pmid': '21178667', 'type': 'BACKGROUND', 'citation': 'Murkin JM. Cerebral oximetry: monitoring the brain as the index organ. Anesthesiology. 2011 Jan;114(1):12-3. doi: 10.1097/ALN.0b013e3181fef5d2. No abstract available.'}, {'pmid': '19372313', 'type': 'BACKGROUND', 'citation': 'Murphy GS, Hessel EA 2nd, Groom RC. Optimal perfusion during cardiopulmonary bypass: an evidence-based approach. Anesth Analg. 2009 May;108(5):1394-417. doi: 10.1213/ane.0b013e3181875e2e.'}, {'pmid': '24161555', 'type': 'BACKGROUND', 'citation': 'Koning NJ, Vonk AB, Meesters MI, Oomens T, Verkaik M, Jansen EK, Baufreton C, Boer C. Microcirculatory perfusion is preserved during off-pump but not on-pump cardiac surgery. J Cardiothorac Vasc Anesth. 2014 Apr;28(2):336-41. doi: 10.1053/j.jvca.2013.05.026. Epub 2013 Oct 23.'}, {'pmid': '26658179', 'type': 'BACKGROUND', 'citation': 'Kara A, Akin S, Ince C. The response of the microcirculation to cardiac surgery. Curr Opin Anaesthesiol. 2016 Feb;29(1):85-93. doi: 10.1097/ACO.0000000000000280.'}, {'pmid': '18603065', 'type': 'BACKGROUND', 'citation': 'den Uil CA, Lagrand WK, Spronk PE, van Domburg RT, Hofland J, Luthen C, Brugts JJ, van der Ent M, Simoons ML. Impaired sublingual microvascular perfusion during surgery with cardiopulmonary bypass: a pilot study. J Thorac Cardiovasc Surg. 2008 Jul;136(1):129-34. doi: 10.1016/j.jtcvs.2007.10.046. Epub 2008 May 2.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the proposed study is to evaluate microcirculatory alterations in patients undergoing open heart surgery under extracorporeal circulation. Positive clinical results evidenced with goal-directed perfusion and cerebral oximetry monitoring could be attributed to preserved microcirculation at tissue level.', 'detailedDescription': 'The aim of the proposed study is to evaluate microcirculatory alterations in patients undergoing open heart surgery under extracorporeal circulation. Microcirculatory changes during cardiac surgery have been investigated mainly during coronary procedures using the conventional extracorporeal circulation. There is no single study in the literature investigating microcirculatory alterations using a perioperative strategy of "physiologic" perfusion. Positive clinical results evidenced with goal-directed perfusion and cerebral oximetry monitoring could be attributed to preserved microcirculation at tissue level.\n\nAll patients will follow the same anaesthetic and perfusion protocol. The protocol for the evaluation of microcirculation will be based on:\n\n* Cerebral near-infrared spectroscopy (rScO2) measurements (INVOS, Covidien-Medtronic Inc.).\n* NIRS-Based Cerebral Autoregulation Monitoring: Analog arterial blood pressure signals will be digitized and then processed with the digital NIRS signals using a personal computer and a special ICM software (University of Cambridge, Cambridge, UK). Monitoring cerebral autoregulation ensures adequate renal perfusion. Hence, brain can be used not just as a target but also as an index organ indicating adequacy of perfusion.\n* Somatic near-infrared spectroscopy (rSsO2) measurements (INVOS, Covidien-Medtronic Inc.).\n* Sublingual mucosal microcirculation measurements during surgery using side dark field (SDF) imaging (MicroScan, Microvision Medical, Amsterdam, The Netherlands).\n\nAll measurements will be performed at the following time points:\n\nT0: after induction of anaesthesia T1: after initiation of cardiopulmonary bypass T2: 10 minutes after cross- clamping the aorta T3: 10 minutes before removing the aortic cross-clamp T4: after weaning from extracorporeal circulation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aged \\> 18 and \\< 85 years with coronary artery disease and/or aortic valve disease undergoing open heart surgery with accepted indications\n\nExclusion Criteria:\n\n* patients undergoing emergency surgery\n* patients in preoperative cardiogenic shock with evidence of tissue malperfusion\n* patients \\> 85 years of age\n* patients with severe peripheral vascular disease'}, 'identificationModule': {'nctId': 'NCT04058860', 'briefTitle': 'Study of Microcirculation During Extracorporeal Circulation in Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'AHEPA University Hospital'}, 'officialTitle': 'Study of Microcirculation During Extracorporeal Circulation in Cardiac Surgery; Challenging Near-infrared Spectroscopy With Microvascular Density and Metabolic Parameters', 'orgStudyIdInfo': {'id': 'AHEPA_CTS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Study Patients', 'description': 'Patients undergoing open heart surgery with minimal invasive extracorporeal circulation (MiECC) according to accepted indications', 'interventionNames': ['Device: NIRS monitoring', 'Device: Cox monitoring', 'Device: Sublingual microscopy']}], 'interventions': [{'name': 'NIRS monitoring', 'type': 'DEVICE', 'description': 'Cerebral and somatic near-infrared spectroscopy (rScO2) measurements', 'armGroupLabels': ['Study Patients']}, {'name': 'Cox monitoring', 'type': 'DEVICE', 'description': 'Cerebral autoregulation monitoring', 'armGroupLabels': ['Study Patients']}, {'name': 'Sublingual microscopy', 'type': 'DEVICE', 'description': 'Sublingual mucosal microcirculation measurements during surgery using side dark field (SDF) imaging', 'armGroupLabels': ['Study Patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Cardiothoracic Department, AHEPA University Hospital', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}], 'overallOfficials': [{'name': 'Kyriakos Anastasiadis, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiothoracic Department, AHEPA University Hospital, Thessaloniki, Greece'}, {'name': 'Helena Argiriadou, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiothoracic Department, AHEPA University Hospital, Thessaloniki, Greece'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AHEPA University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic - MITG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Cardiac Surgery', 'investigatorFullName': 'Kyriakos Anastasiadis', 'investigatorAffiliation': 'AHEPA University Hospital'}}}}