Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-02-01 @ 2:22 PM
Study NCT ID:
NCT03608956
Status:
WITHDRAWN
Last Update Posted:
2025-12-18
First Post:
2018-06-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Renal Oxygen Saturation and Its Association With Acute Renal Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Withdrawn prior to recruitment due to institutional changes', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2019-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2018-06-28', 'studyFirstSubmitQcDate': '2018-07-31', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early prediction of postoperative acute renal injury with TEE', 'timeFrame': 'Intraoperative period', 'description': 'Intraoperative renal blood flow assessment with TEE'}, {'measure': 'Early prediction of postoperative acute renal injury with transcutaneous renal regional oxygen saturation measured with NIRS', 'timeFrame': 'Intraoperative period', 'description': 'Renal oxygenation values gained from NIRS monitor during the surgery'}, {'measure': 'Acute kidney injury', 'timeFrame': 'Postoperative 1 week', 'description': 'AKI is staged according to KDIGO'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['regional oximetry', 'cerebral oximetry'], 'conditions': ['Acute Kidney Injury', 'Children', 'Cardiac Surgery']}, 'descriptionModule': {'briefSummary': 'Peri-operative renal dysfunction is a major mortality and morbidity cause following cardiac and major vascular surgery. Although several intra-operative strategies are proposed for better outcomes, no effective and fast resulting test is available to be done in operating rooms to assess renal functions. Urine and blood markers as serum creatinine, urine output, fractional excretion of sodium and urea are used for early diagnosis of acute renal injury. Near infrared spectroscopy (NIRS) assesses tissue oxygenation especially cerebral regional oxygen saturation. The benefit of NIRS followups of cerebral and somatic (liver, kidney, mesentery) oxygenation in pediatric cardiovascular surgery patients are demonstrated by studies.', 'detailedDescription': 'Peri-operative renal dysfunction is a major mortality and morbidity cause following cardiac and major vascular surgery. Patients undergoing cardiac surgery with more than one risk factor for postoperative renal insufficiency develop clinical significant renal dysfunction which results in extended length of stay in 1/5 of the patients .At least50% of the postoperative renal dysfunction is associated with development of renal hypoperfusion during cardiopulmonary bypass or aortic cross clamping. Although several intra-operative strategies are proposed for better outcomes, no effective and fast resulting test is available to be done in operating rooms to assess renal functions. Urine and blood markers as serum creatinine, urine output, fractional excretion of sodium and urea are used for early diagnosis of acute renal injury. In this study definition and classification of AKI (acute kidney injury) will be done according to KDIGO (kidney disease improving global outcome) criteria.\n\nRenal perfusion can be assessed by renal artery measurements done by ultrasound imaging.The same assessment can also be done by transesophageal echocardiography (TEE).\n\nNear infrared spectroscopy (NIRS) assesses tissue oxygenation especially cerebral regional oxygen saturation. NIRS measures regional oxygenation (rSO=oxyhemoglobin/ total Hemoglobin) by determining oxy- and deoxy- hemoglobin signals.\n\nThe probe placed on frontotemporal region has two sensors and a light source. Data is gained from sensors 3cm apart from the extracranial tissue and 4cm apart from the brain tissue; value is formed from calculation of the difference of these data. The benefit of NIRS followups of cerebral and somatic (liver, kidney, mesentery) oxygenation in pediatric cardiovascular surgery patients are demonstrated by studies.\n\nThe investigators aimed to investigate the association of postoperative acute renal injury and the change in peroperative renal blood flow and renal oxygenation values; additionally to establish wether it can be used as a fast responding and efficient method in evaluating renal function in the operating room settings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '1 Month', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric patients who meet the inclusion criteria and who will undergo cardiac surgery in our hospital will be included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pediatric patients\n* cardiovascular surgery\n* Written informed consent\n* Peroperative TEE assessment\n\nExclusion Criteria:\n\n* Patients whose follow up cannot be done with TEE (ie Patients whose body weight is less than 5 kg, patients with esophageal pathologies)\n* Patients with renal insufficiency\n\nPatients whose TEE evaluation cannot be done optimally will be left out of the study'}, 'identificationModule': {'nctId': 'NCT03608956', 'briefTitle': 'Renal Oxygen Saturation and Its Association With Acute Renal Injury', 'organization': {'class': 'OTHER', 'fullName': 'Marmara University'}, 'officialTitle': 'RENAL BLOOD FLOW MEASUREMENT WITH TRANSESOPHAGEAL ECHOCARDIOGRAPHY:RENAL OXYGEN SATURATION AND ITS ASSOCIATION WITH ACUTE RENAL INJURY', 'orgStudyIdInfo': {'id': '09.2017.642'}}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'state': 'Turkey', 'country': 'Turkey (Türkiye)', 'facility': 'Marmara University Pendik Education and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Alper Kararmaz, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Marmara University Pendik Education and Research Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marmara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof. Dr', 'investigatorFullName': 'Mustafa Kemal Arslantas', 'investigatorAffiliation': 'Marmara University'}}}}