Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-27 @ 11:57 PM
Study NCT ID:
NCT05179434
Status:
UNKNOWN
Last Update Posted:
2022-01-24
First Post:
2021-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Retrograde Reperfusion of Renal Graft to Reduce Ischemic-reperfusion Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-06', 'studyFirstSubmitDate': '2021-12-16', 'studyFirstSubmitQcDate': '2021-12-16', 'lastUpdatePostDateStruct': {'date': '2022-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Renal graft and recipients survival', 'timeFrame': '3 months', 'description': 'Renal graft function quality and recipients survival'}], 'secondaryOutcomes': [{'measure': 'Median serum creatinine levels', 'timeFrame': '1 months', 'description': 'Normalization of creatinine levels in dynamics'}, {'measure': 'Median serum urea levels', 'timeFrame': '1 months', 'description': 'Normalization of serum urea levels in dynamics'}, {'measure': 'Median glomerular filtration rate (GFR) levels', 'timeFrame': '1 month', 'description': 'Normalization of glomerular filtration ratio (GFR) in dynamics'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Transplantation', 'Ischemic Reperfusion Injury', 'Reperfusion']}, 'referencesModule': {'references': [{'pmid': '26786360', 'type': 'BACKGROUND', 'citation': 'Tasoulis MK, Douzinas EE. Hypoxemic reperfusion of ischemic states: an alternative approach for the attenuation of oxidative stress mediated reperfusion injury. J Biomed Sci. 2016 Jan 19;23:7. doi: 10.1186/s12929-016-0220-0.'}, {'pmid': '27815464', 'type': 'BACKGROUND', 'citation': 'Molacek J, Opatrny V, Matejka R, Baxa J, Treska V. Retrograde Oxygen Persufflation of Kidney - Experiment on an Animal. In Vivo. 2016 11-12;30(6):801-805. doi: 10.21873/invivo.10997.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate whether retrograde venous reperfusion of a renal graft before antegrade arterial reperfusion can reduce ischemic-reperfusion injury.\n\nAll registered eligible candidates for kidney transplant will be randomized to receive either:\n\n* retrograde venous, then arterial reperfusion or\n* antegrade arterial reperfusion.', 'detailedDescription': 'According to our hypothesis, retrograde venous reperfusion prevents and reduces the immediate and long-term effects of renal allograft ischemic-reperfusion injury.\n\nFor the study Chi-square method of sample size estimation with a=0,05, b=0,20 required a 14 subject per group.\n\nThe study will include 30 potential kidney recipients for both group aged 18-60 years who will receive kidney transplants. Only adult patients undergoing primary living donor kidney transplantation with standard three-component immunosuppression will be enrolled to the study.The main study group will consist of 15 patients with retrograde graft reperfusion, and control group - will include 15 kidney recipients with only conventional antegrade arterial reperfusion (without retrograde reperfusion).\n\nPatients of the study group with standard kidney implantation surgery will undergo retrograde reperfusion through the renal vein after venous anastomosis. After the venous anastomosis of the graft, an arterial anastomosis is applied with the renal artery without tightening the suture to leave a lumen sufficient for the outflow of retrograde blood. Then the retrograde blood flow through the renal vein is started, venous blood fills the graft and flows through the renal artery through the lumen of the anastomosis in a volume of 80-100 ml. Retrograde blood collected for gas and lactate analysis at the beginning of reperfusion, at the first minute and at the fifth minute. Further, the sutures of the arterial anastomosis are tightened, and after tying, a typical antegrade reperfusion of the graft through the renal artery is performed.\n\nPatients in the control group will undergo standard kidney implantation surgery with typical antegrade arterial reperfusion.\n\nT-test and Mann-Whitney test will be used to compare the median of urea, creatinine levels in serum and glomerular filtration rate (GFR) on the 1st, 7th, 14th, 30th, 60th postoperative day.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with end-stage kidney disease who are ready for kidney transplantation;\n* Panel reactive antibodies (PRA) less than 20%.\n* informed consent to participate in the study.\n\nExclusion Criteria:\n\n* recipients preparing for combined organ transplantation;\n* recipients with previously performed transplantation of another organ;\n* recipients preparing for transplantation with a different immunosuppressive regimen;\n* upcoming blood group incompatibility (AB0-i) transplant;\n* PRA antibodies more than 20%;'}, 'identificationModule': {'nctId': 'NCT05179434', 'briefTitle': 'A Study of Retrograde Reperfusion of Renal Graft to Reduce Ischemic-reperfusion Injury', 'organization': {'class': 'OTHER', 'fullName': 'West Kazakhstan Medical University'}, 'officialTitle': 'A Randomized Clinical Study of Retrograde Reperfusion of Renal Graft to Reduce Ischemic-Reperfusion Injury', 'orgStudyIdInfo': {'id': '116.23.11.2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Retrograde graft reperfusion', 'description': 'Kidney transplantation with retrograde venous reperfusion of renal graft followed by arterial reperfusion', 'interventionNames': ['Procedure: Retrograde renal graft reperfusion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional antegrade perfusion', 'description': 'Kidney transplantation with conventional arterial reperfusion of renal graft (without retrograde venous reperfusion)', 'interventionNames': ['Procedure: Conventional antegrade renal graft reperfusion (without retrograde reperfusion)']}], 'interventions': [{'name': 'Retrograde renal graft reperfusion', 'type': 'PROCEDURE', 'otherNames': ['Venous reperfusion'], 'description': 'Retrograde venous reperfusion of the renal graft during the kidney transplant procedure with consequent arterial reperfusion', 'armGroupLabels': ['Retrograde graft reperfusion']}, {'name': 'Conventional antegrade renal graft reperfusion (without retrograde reperfusion)', 'type': 'PROCEDURE', 'otherNames': ['Arterial reperfusion'], 'description': 'Conventional arterial antegrade renal graft reperfusion during the kidney transplant procedure', 'armGroupLabels': ['conventional antegrade perfusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '040017', 'city': 'Aktobe', 'status': 'RECRUITING', 'country': 'Kazakhstan', 'contacts': [{'name': 'Myltykbay Rysmakhanov, MD', 'role': 'CONTACT', 'email': 'mrtransplantolog@gmail.com', 'phone': '+7 777 036 5690'}, {'name': 'Aibolat Smagulov, MD', 'role': 'CONTACT', 'email': 'smagulov.aibolat@gmail.com', 'phone': '+7 778 869 6644'}], 'facility': 'West Kazakhstan Medical University', 'geoPoint': {'lat': 50.27969, 'lon': 57.20718}}], 'centralContacts': [{'name': 'Myltykbay Rysmakhanov', 'role': 'CONTACT', 'email': 'mrtransplantolog@gmail.com', 'phone': '+7 777 036 5690'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West Kazakhstan Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD-doctoral, Department of Surgery No 2, MD', 'investigatorFullName': 'Myltykbay Rysmakhanov', 'investigatorAffiliation': 'West Kazakhstan Medical University'}}}}