Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:22 AM
Study NCT ID:
NCT07044102
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-11
First Post:
2025-06-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Continuous Low Tidal Volume Ventilation During Cardiopulmonary Bypass on Renal Resistive Index
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-08', 'studyFirstSubmitDate': '2025-06-23', 'studyFirstSubmitQcDate': '2025-06-23', 'lastUpdatePostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Renal resistive ındex', 'timeFrame': 'Postoperative 45 minutes', 'description': 'Measurement of Changes in Renal Resistive Index Associated With Low Tidal Volume and Apneic Ventilation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Complications']}, 'descriptionModule': {'briefSummary': 'Postoperative acute kidney injury following cardiopulmonary bypass surgery represents a significant barrier to patient recovery and is closely associated with increased postoperative morbidity and mortality. Studies have shown that the incidence of AKI aftercardiopulmonary bypass surgeryranges between 5% and 30%.\n\nThe Renal Resistive Index, measured by Doppler ultrasonography, is an increasingly utilized parameter that provides valuable insights into renal hemodynamics and vascular resistance. A normal RRI is typically below 0.70; elevated values may indicate increased renal vascular resistance or microvascular damage. Bossard et al. demonstrated that increased RRI in the early postoperative period is associated with the development of AKI. Early evaluation of renal blood flow thus facilitates prompt detection of AKI. Both preoperative and postoperative RRI measurements are considered useful tools for identifying early renal dysfunction. Monitoring RRI before and after CABG may provide critical information for preventing postoperative renal complications.', 'detailedDescription': 'Postoperative acute kidney injury following cardiopulmonary bypass surgery represents a significant barrier to patient recovery and is closely associated with increased postoperative morbidity and mortality. Studies have shown that the incidence of AKI after CABG ranges between 5% and 30%.\n\nThe Renal Resistive Index, measured by Doppler ultrasonography, is an increasingly utilized parameter that provides valuable insights into renal hemodynamics and vascular resistance. A normal RRI is typically below 0.70; elevated values may indicate increased renal vascular resistance or microvascular damage. Bossard et al. demonstrated that increased RRI in the early postoperative period is associated with the development of AKI. Early evaluation of renal blood flow thus facilitates prompt detection of AKI. Both preoperative and postoperative RRI measurements are considered useful tools for identifying early renal dysfunction. Monitoring RRI before and after CABG may provide critical information for preventing postoperative renal complications.In recent years, significant advancements have been made in both surgical and anesthetic techniques in cardiac surgery. During CABG, the commonly used ventilation strategy during cardiopulmonary bypass is apneic ventilation. However, low tidal volume ventilation has been proposed as an alternative, with a growing body of literature supporting its use. LTV has been associated with reduced postoperative pulmonary complications, earlier extubation, and prevention of atelectasis and pulmonary edema.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'In the Low Tidal Volume (LTV) Group, mechanical ventilation will be set to deliver tidal volumes of 3-4 mL/kg based on ideal body weight, with a respiratory rate of approximately 12 breaths per minute, ensuring a minute ventilation not exceeding 12 L/min. Positive end-expiratory pressure (PEEP) will be maintained between 5-8 cmH₂O, and the inspired oxygen fraction (FiO₂) will be set at 50%.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for elective cardiac bypass surgery\n* Male and female patients over 18 years of age\n* Patients with an American Society of Anesthesiologists (ASA) physical status classification of II, III, or IV\n\nExclusion Criteria:\n\n* Chronic renal failure requiring dialysis\n* Patients requiring emergency surgery'}, 'identificationModule': {'nctId': 'NCT07044102', 'briefTitle': 'The Effect of Continuous Low Tidal Volume Ventilation During Cardiopulmonary Bypass on Renal Resistive Index', 'organization': {'class': 'OTHER', 'fullName': 'Konya City Hospital'}, 'officialTitle': 'The Effect of Continuous Low Tidal Volume Ventilation During Cardiopulmonary Bypass on Renal Resistive Index', 'orgStudyIdInfo': {'id': 'bypass surgery'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients Undergoing Low Tidal Volume Ventilation During CABG', 'interventionNames': ['Other: Patients Undergoing Apneic Ventilation During CABG']}, {'label': 'Patients Managed With Apneic Ventilation During Cardiopulmonary Bypass"', 'interventionNames': ['Other: Patients Undergoing Low Tidal Volume Ventilation During CABG']}], 'interventions': [{'name': 'Patients Undergoing Low Tidal Volume Ventilation During CABG', 'type': 'OTHER', 'description': 'Postoperative Evaluation of Renal Resistive Index Using Doppler Ultrasound After Cardiopulmonary Bypass', 'armGroupLabels': ['Patients Managed With Apneic Ventilation During Cardiopulmonary Bypass"']}, {'name': 'Patients Undergoing Apneic Ventilation During CABG', 'type': 'OTHER', 'description': 'Postoperative Evaluation of Renal Resistive Index Using Doppler Ultrasound After Cardiopulmonary Bypass"', 'armGroupLabels': ['Patients Undergoing Low Tidal Volume Ventilation During CABG']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Konya', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Esra GOGER, MD', 'role': 'CONTACT', 'email': 'dr.esragoger@gmail.com', 'phone': '5359337429', 'phoneExt': '+90'}], 'facility': 'Konya City Hospital', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Konya City Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Specialist Doctor, MD Anesthesiology and Reanimation', 'investigatorFullName': 'Esra GÖGER', 'investigatorAffiliation': 'Konya City Hospital'}}}}