Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2026-02-25 @ 3:38 AM
Study NCT ID:
NCT03641833
Status:
UNKNOWN
Last Update Posted:
2018-08-22
First Post:
2018-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identification of Factors Causing Postoperative Cognitive Dysfunction in Patients Undergoing Cardiac Surgery With CPB
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000079690', 'term': 'Postoperative Cognitive Complications'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-20', 'studyFirstSubmitDate': '2018-07-15', 'studyFirstSubmitQcDate': '2018-08-20', 'lastUpdatePostDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Determine factors causing POCD', 'timeFrame': '3 years', 'description': 'Patients will complete questionares: mini mental state examination (MMSE), Trial making and addenbrooke test one day before and 10 days after the surgery. We are going to compare change in tests results after surgery and find correlation with brain biomarkers and blood flow speed during surgery'}], 'primaryOutcomes': [{'measure': 'Brain blood flow speed changes during surgery and correlation with POCD', 'timeFrame': '3 years', 'description': 'Transcranial Doppler will be performed to evaluate a.cerebri media blood flow speed during surgery using the 2MHz TCD ultrasound transducer over the temporal area. By adjusting the probe the curve of arteria will appear. Target measurement- mean flow velocity (MFV is measured in cm/s).'}], 'secondaryOutcomes': [{'measure': 'Brain biomarker GFAP concentration chances before and after surgery and correlation with POCD.', 'timeFrame': '3 years', 'description': 'Blood sample for brain biomarkers GFAP will be taken after induction, 24 and 48 hours after surgery. GFAP concentration in blood serum is measured in ng/ml'}, {'measure': 'Brain biomarker neurofilaments concentration chances before and after surgery and correlation with POCD.', 'timeFrame': '3 years', 'description': 'Blood sample for brain biomarker neurofilaments will be taken after induction, 24 and 48 hours after surgery. GFAP concentration in blood serum is measured in pg/ml'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cardiac', 'surgery', 'postoperative cognitive dysfunction', 'bypass', 'brain biomarkers', 'transcranial Doppler'], 'conditions': ['Postoperative Cognitive Dysfunction']}, 'descriptionModule': {'briefSummary': 'The incidence of cognitive decline occurs in 53% of patients after cardiac surgery. Causes of POCD can be various: age, duration of cardiac bypass, medicaments and many others. The aim of this study is to determine factors causing postoperative cognitive dysfunction (POCD) and to identify which of them are most important', 'detailedDescription': 'Prospective case-control study included patients undergoing cardiac at Clinic of Cardiac, Vascular and Thoracic Surgery, Lithuanian University of Health Sciences. Inclusion criteria is: 1) cardiac output \\> 35%; 2) no agents affecting central nervous system; 3) no neuropathology; 5) no multiple organ dysfunction. Patients will have to perform mini mental state examination (MMSE), Trial making, addenbrooke tests before and 7 days after surgery. Brain biomarkers glial fibrillary acid protein (GFAP) and neurofilaments will be taken after induction, 24 and 48 hours after surgery. Transcranial Doppler will be performed to evaluate a.cerebri media blood flow speed during surgery.\n\nAfter these test, the investigators are going to examine data about patient and operation, recognize factors causing POCD and identify the most important of them.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study include patients undergoing cardiac at Clinic of Cardiac, Vascular and Thoracic Surgery, Lithuanian University of Health Sciences', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Coronary artery bypass grafting or/and heart valve surgery;\n* Patients age\\>18years\n* Cardiac output \\>35%\n\nExclusion Criteria:\n\n* Patient disagreement;\n* Diseases causing cognitive dysfunction;\n* Multi organic deficiency;\n* Agents affecting central nervous system'}, 'identificationModule': {'nctId': 'NCT03641833', 'briefTitle': 'Identification of Factors Causing Postoperative Cognitive Dysfunction in Patients Undergoing Cardiac Surgery With CPB', 'organization': {'class': 'OTHER', 'fullName': 'Lithuanian University of Health Sciences'}, 'officialTitle': 'Identification of Factors Causing Postoperative Cognitive Dysfunction in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass (CPB)', 'orgStudyIdInfo': {'id': 'POCD-1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'blood sample for brain biomarkers', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['device'], 'description': 'Transcranial Doppler will be performed to evaluate a.cerebri media blood flow speed during surgery.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '50221', 'city': 'Kaunas', 'state': 'Outside US/Canada/Australia', 'status': 'RECRUITING', 'country': 'Lithuania', 'contacts': [{'name': 'Rasa Bukauskiene', 'role': 'CONTACT', 'email': 'rasa.bukauskiene@lsmuni.lt', 'phone': '867111033'}], 'facility': 'Lithuanian University of Health Sciences', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}], 'centralContacts': [{'name': 'Rasa Bukauskiene', 'role': 'CONTACT', 'email': 'rasa.bukauskiene@lsmuni.lt', 'phone': '867111033'}, {'name': 'Edmundas Sirvinskas, Professor', 'role': 'CONTACT', 'email': 'edmundas.sirvinskas@lsmuni.lt', 'phone': '+37037326171'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rasa Bukauskiene', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Physician anaesthesiologist', 'investigatorFullName': 'Rasa Bukauskiene', 'investigatorAffiliation': 'Lithuanian University of Health Sciences'}}}}