Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:54 AM
Study NCT ID:
NCT07324694
Status:
RECRUITING
Last Update Posted:
2026-01-12
First Post:
2025-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Intraoperative Hemodynamic Instability on Outcomes in Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D000071257', 'term': 'Emergence Delirium'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 230}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-02-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-09', 'studyFirstSubmitDate': '2025-12-23', 'studyFirstSubmitQcDate': '2025-12-23', 'lastUpdatePostDateStruct': {'date': '2026-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Composite Adverse Events', 'timeFrame': 'Up to 30 days post-operation', 'description': 'A composite endpoint defined as the occurrence of any of the following within 30 days post-surgery: Postoperative Delirium (assessed by CAM-ICU), Acute Kidney Injury (KDIGO criteria stage 1 or higher), Stroke (new neurological deficit confirmed by imaging), or All-cause Mortality.'}], 'secondaryOutcomes': [{'measure': 'Duration of Mechanical Ventilation', 'timeFrame': 'Up to 30 days', 'description': 'Time from ICU admission to successful extubation (in hours).'}, {'measure': 'Length of Hospital Stay', 'timeFrame': 'Up to 30 days', 'description': 'Total duration of hospital stay from surgery to discharge (in days)'}, {'measure': 'Length of Intensive Care Unit (ICU) Stay', 'timeFrame': 'Up to 30 days', 'description': 'Time from admission to the Intensive Care Unit immediately after surgery until discharge to the ward (in days).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intraoperative Hypotension', 'Cardiopulmonary Bypass', 'Mean Arterial Pressure', 'Cohort Study'], 'conditions': ['Cardiac Surgery', 'Intraoperative Hemodynamic Instability', 'Postoperative Complication', 'Acute Kidney Injury', 'Postoperative Delirium (POD)']}, 'referencesModule': {'references': [{'pmid': '39581994', 'type': 'RESULT', 'citation': 'Shen X, Tao H, Chen W, Sun J, Jin R, Zhang W, Hong L, Zhang C. Perioperative blood pressure variability as a risk factor for postoperative delirium in the patients receiving cardiac surgery. BMC Anesthesiol. 2024 Nov 25;24(1):424. doi: 10.1186/s12871-024-02817-x.'}, {'pmid': '37739903', 'type': 'RESULT', 'citation': "D'Amico F, Fominskiy EV, Turi S, Pruna A, Fresilli S, Triulzi M, Zangrillo A, Landoni G. Intraoperative hypotension and postoperative outcomes: a meta-analysis of randomised trials. Br J Anaesth. 2023 Nov;131(5):823-831. doi: 10.1016/j.bja.2023.08.026. Epub 2023 Sep 20."}, {'pmid': '30624247', 'type': 'RESULT', 'citation': 'Buitenwerf E, Boekel MF, van der Velde MI, Voogd MF, Kerstens MN, Wietasch GJKG, Scheeren TWL. The haemodynamic instability score: Development and internal validation of a new rating method of intra-operative haemodynamic instability. Eur J Anaesthesiol. 2019 Apr;36(4):290-296. doi: 10.1097/EJA.0000000000000941.'}]}, 'descriptionModule': {'briefSummary': 'Intraoperative hemodynamic instability (IOHI) is a common occurrence during cardiac surgery and is associated with organ hypoperfusion. However, the specific impact of IOHI on composite adverse outcomes remains unclear. This prospective cohort study aims to evaluate the association between intraoperative hemodynamic instability (defined as MAP \\< 65 mmHg or vasopressor requirement) and major postoperative complications (Delirium, Acute Kidney Injury, Stroke, or Mortality) in adult patients undergoing elective cardiac surgery with cardiopulmonary bypass.', 'detailedDescription': 'Hemodynamic instability during cardiac surgery is a critical factor influencing postoperative recovery. While transient hypotension is common, prolonged instability may lead to end-organ damage due to hypoperfusion. This prospective observational study will be conducted at the University of Health Sciences Gazi Yasargil Training and Research Hospital.\n\nPatients scheduled for elective cardiac surgery (Coronary Artery Bypass Grafting, Valve replacement/repair, or combined procedures) utilizing cardiopulmonary bypass will be enrolled. Intraoperative hemodynamic data, including Mean Arterial Pressure (MAP), heart rate, and vasoactive medication requirements, will be recorded.\n\nPatients will be categorized into two groups based on intraoperative stability:\n\n1. Hemodynamic Instability Group: Patients experiencing MAP \\< 65 mmHg for more than 5 minutes continuously or requiring significant vasopressor/inotropic support to maintain target pressure.\n2. Stable Group: Patients maintaining hemodynamic stability without significant hypotensive episodes.\n\nThe primary endpoint is a composite of major adverse events within 30 days, including Postoperative Delirium (assessed via CAM-ICU), Acute Kidney Injury (KDIGO criteria), Stroke, and All-cause Mortality. Secondary endpoints include the duration of mechanical ventilation and length of ICU/hospital stay. The study aims to provide evidence-based thresholds for intraoperative blood pressure management to improve patient outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients undergoing elective cardiac surgery with cardiopulmonary bypass at a tertiary care university hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 years or older.\n* Scheduled for elective cardiac surgery (CABG, Valve replacement/repair, or combined procedures).\n* Surgery performed under cardiopulmonary bypass (CPB).\n* Preoperative sinus rhythm.\n* Signed informed consent form.\n\nExclusion Criteria:\n\n* Emergency or salvage surgery.\n* Off-pump coronary artery bypass grafting.\n* Preoperative mechanical circulatory support (IABP, ECMO) requirement.\n* Pre-existing chronic renal failure requiring dialysis (HD/PD).\n* Pre-existing cognitive impairment, dementia, or history of psychiatric disorders affecting cooperation.\n* Pregnancy.'}, 'identificationModule': {'nctId': 'NCT07324694', 'briefTitle': 'Impact of Intraoperative Hemodynamic Instability on Outcomes in Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital'}, 'officialTitle': 'Impact of Intraoperative Hemodynamic Instability on Postoperative Major Adverse Events in Cardiac Surgery Patients: A Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'GYTRH-KVC-IOHI-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hemodynamic Instability Group', 'description': 'Patients who exhibit intraoperative hemodynamic instability, defined as Mean Arterial Pressure (MAP) \\< 65 mmHg for \\>5 minutes continuously, or requiring vasopressor/inotropic support to maintain MAP.'}, {'label': 'Hemodynamically Stable Group', 'description': 'Patients who maintain intraoperative hemodynamic stability without significant hypotension episodes (MAP \\> 65 mmHg) or vasopressor requirement beyond baseline anesthesia induction.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21070', 'city': 'Diyarbakır', 'state': 'Diyarbakır', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Osman Uzundere, M.D.', 'role': 'CONTACT', 'email': 'osmanuzundere@gmail.com', 'phone': '+905330206362'}], 'facility': 'Gazi Yaşargil Training and Research Hospital', 'geoPoint': {'lat': 37.91363, 'lon': 40.21721}}], 'centralContacts': [{'name': 'Osman Uzundere, M.D.', 'role': 'CONTACT', 'email': 'osmanuzundere@gmail.com', 'phone': '+905330206362'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Osman Uzundere', 'investigatorAffiliation': 'Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital'}}}}