Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-28 @ 1:31 AM
Study NCT ID:
NCT05538234
Status:
RECRUITING
Last Update Posted:
2023-09-07
First Post:
2022-09-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers of Kidney Function in Transplant Medicine
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D020858', 'term': 'Tissue and Organ Harvesting'}, {'id': 'D016377', 'term': 'Organ Transplantation'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples will be collected from the study participants.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-06', 'studyFirstSubmitDate': '2022-09-09', 'studyFirstSubmitQcDate': '2022-09-09', 'lastUpdatePostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity of kidney dysfunction biomarkers', 'timeFrame': 'up to 90 days after the procedure', 'description': 'Sensitivity of kidney dysfunction biomarkers will be assessed using the Kidney Donor Risk Index and Kidney Donor Profile Index'}], 'secondaryOutcomes': [{'measure': 'Comparison of levels of kidney dysfunction biomarkers between DBD donors (Donation after Brain Death) and DCD donors (Donation after Cardiac Death', 'timeFrame': 'during baseline data collection', 'description': 'levels of kidney dysfunction biomarkers between DBD donors (Donation after Brain Death) and DCD donors (Donation after Cardiac Death will be assessed.'}, {'measure': 'Correlation of Acute Kidney Injury biomarkers in DCD donors with the time of warm ischemia', 'timeFrame': 'during organ harvesting', 'description': 'Correlation of Acute Kidney Injury biomarkers in DCD donors with the time of warm ischemia will be assessed.'}, {'measure': 'Predictive value of Acute Kidney Injury biomarkers in organ recipients', 'timeFrame': 'up to 90 days after transplantation', 'description': 'The predictive value of Acute Kidney Injury biomarkers in organ recipients for worsened function of the transplanted kidney will be assessed'}, {'measure': 'Association between donor kidney dysfunction with selected risk factors', 'timeFrame': 'up to 90 days after transplantation', 'description': 'Association between donor kidney dysfunction with selected risk factors will be assessed (ion disbalance, circulatory instability)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['organ donor', 'organ recipient', 'transplant medicine', 'acute kidney injury'], 'conditions': ['Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'Biomarkers of kidney function in transplant medicine is an international, multicentre, observational, non-interventional study.\n\nThe project is aimed at monitoring biomarkers of acute kidney dysfunction in deceased organ donors, living organ donors, and organ recipients.', 'detailedDescription': 'The study is observational, without any changes from the standard care, including only selected laboratory assessments, from standard blood samples collected from the donors/recipients.\n\nInformed consent will be required from living donors and recipients.\n\nThe mainly used current criteria of organ acceptability in transplant medicine include urine output and laboratory parameters of acute kidney dysfunction - serum levels of urea and creatinine. Literary sources show that these classic criteria of kidney dysfunction develop only with a significant reduction of (glomerular and tubular) kidney functions and return to normal only slowly after the function of the kidneys has been restored.\n\nNew possibilities of early kidney dysfunction diagnostics are being studied, using more sensitive tests - determination of biomarkers of acute kidney dysfunction. These may serve as decisive criteria for the safe use of organs from so-called marginal donors and identify early serious impairment of kidney function in donors with preserved urine output, without fulfilled criteria of acute kidney injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Living and deceased organ donors, organ recipients.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18+\n* signed Informed Consent in case of living organ donors and recipients\n* fulfillment of all legal requirements for organ harvesting from a deceased donor\n* fulfillment of all ethical principles of end-of-life patient care\n* medical suitability of organs for transplant use\n\nExclusion Criteria:\n\n\\- disapproval of family members with the enrolment of the patient in the study'}, 'identificationModule': {'nctId': 'NCT05538234', 'briefTitle': 'Biomarkers of Kidney Function in Transplant Medicine', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Ostrava'}, 'officialTitle': 'Biomarkers of Kidney Function in Transplant Medicine', 'orgStudyIdInfo': {'id': 'KARIM-827/2021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-living organ donors', 'description': 'Group of non-living donors', 'interventionNames': ['Diagnostic Test: Laboratory values - baseline', 'Other: Medical information 12 hours before organ harvesting', 'Other: Medical information during organ harvesting/transplantation', 'Procedure: Organ harvesting']}, {'label': 'Living organ donors', 'description': 'Group of living organ donors', 'interventionNames': ['Diagnostic Test: Laboratory values - baseline', 'Diagnostic Test: Laboratory values - 12 hours after reperfusion', 'Diagnostic Test: Laboratory values - 48 hours after reperfusion', 'Diagnostic Test: Laboratory values - 7 days after reperfusion', 'Diagnostic Test: Laboratory values - 90 days after reperfusion', 'Other: Medical information during organ harvesting/transplantation', 'Procedure: Organ harvesting']}, {'label': 'Organ recipients', 'description': 'Group of organ recipients', 'interventionNames': ['Diagnostic Test: Laboratory values - baseline', 'Diagnostic Test: Laboratory values - 12 hours after reperfusion', 'Diagnostic Test: Laboratory values - 48 hours after reperfusion', 'Diagnostic Test: Laboratory values - 7 days after reperfusion', 'Diagnostic Test: Laboratory values - 90 days after reperfusion', 'Other: Medical information during organ harvesting/transplantation', 'Procedure: Organ transplantation']}], 'interventions': [{'name': 'Laboratory values - baseline', 'type': 'DIAGNOSTIC_TEST', 'description': 'Baseline laboratory values will be obtained', 'armGroupLabels': ['Living organ donors', 'Non-living organ donors', 'Organ recipients']}, {'name': 'Medical information 12 hours before organ harvesting', 'type': 'OTHER', 'description': '* average hourly diuresis\n* hypotension MAP\\<65 Torr longer than 30 minutes (YES/NO)\n* Furosemide administration (YES/NO)\n* Mannitol administration (YES/NO)\n* administration of anti-diuretic hormone (YES/NO)\n* administration of vasopressors (YES/NO)\n* polyuria \\>3ml/kg/h (YES/NO)\n* nephrotoxic agents during hospitalization (YES/NO)', 'armGroupLabels': ['Non-living organ donors']}, {'name': 'Laboratory values - 12 hours after reperfusion', 'type': 'DIAGNOSTIC_TEST', 'description': 'Laboratory values will be obtained 12 hours after reperfusion', 'armGroupLabels': ['Living organ donors', 'Organ recipients']}, {'name': 'Laboratory values - 48 hours after reperfusion', 'type': 'DIAGNOSTIC_TEST', 'description': 'Laboratory values will be obtained 48 hours after reperfusion', 'armGroupLabels': ['Living organ donors', 'Organ recipients']}, {'name': 'Laboratory values - 7 days after reperfusion', 'type': 'DIAGNOSTIC_TEST', 'description': 'Laboratory values will be obtained 7 days after reperfusion', 'armGroupLabels': ['Living organ donors', 'Organ recipients']}, {'name': 'Laboratory values - 90 days after reperfusion', 'type': 'DIAGNOSTIC_TEST', 'description': 'Laboratory values will be obtained 90 days after reperfusion', 'armGroupLabels': ['Living organ donors', 'Organ recipients']}, {'name': 'Medical information during organ harvesting/transplantation', 'type': 'OTHER', 'description': 'Medical information during organ harvesting/transplantation\n\n* hypotension MAP 65 Torr \\> 5 minutes (YES/NO)\n* vasopressor support (YES/NO, duration in minutes)', 'armGroupLabels': ['Living organ donors', 'Non-living organ donors', 'Organ recipients']}, {'name': 'Organ harvesting', 'type': 'PROCEDURE', 'description': 'Organ harvesting for transplant', 'armGroupLabels': ['Living organ donors', 'Non-living organ donors']}, {'name': 'Organ transplantation', 'type': 'PROCEDURE', 'description': 'Transplantation of the harvested organ', 'armGroupLabels': ['Organ recipients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70852', 'city': 'Ostrava', 'state': 'Moravian-Silesian Region', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Jiří Hynčica', 'role': 'CONTACT', 'email': 'jiri.hyncica@fno.cz', 'phone': '0042059737', 'phoneExt': '2587'}, {'name': 'Peter Sklienka, MD, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Ostrava', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}], 'centralContacts': [{'name': 'Jiří Hynčica', 'role': 'CONTACT', 'email': 'jiri.hyncica@fno.cz', 'phone': '0042059737', 'phoneExt': '2587'}], 'overallOfficials': [{'name': 'Peter Sklienka, MD, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Ostrava'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data may be provided upon request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Ostrava', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}