Ignite Creation Date:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2026-01-01 @ 1:23 AM
Study NCT ID:
NCT06598228
Status:
COMPLETED
Last Update Posted:
2024-09-23
First Post:
2024-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Kidney Injury and Recovery Mode in Pediatric Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 700}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-19', 'studyFirstSubmitDate': '2024-09-12', 'studyFirstSubmitQcDate': '2024-09-12', 'lastUpdatePostDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Graft survival', 'timeFrame': 'Based on the most recent follow-up before December 31, 2023. The investigators collected clinical data of patients from 2014 to 2018, and followed enrolled participants until at least 5 years after surgery', 'description': 'Loss of graft is defined as patient death or secondary transplantation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Acute Kidney Injury', 'Pediatric Liver Transplantation']}, 'descriptionModule': {'briefSummary': 'Acute kidney injury (AKI) is a common complication after pediatric liver transplantation (PLT), and renal impairment after LT has proven to be related with increased graft failure and mortality. The recovery mode of kidney injury after PLT has not been systematically studied. Therefore, in this study the investigators aimed to systematically evaluate prognosis of AKI after PLT, combine the recovery mode of AKI with related risk factors, and establish a relationship between AKI and CKD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study was conducted on pediatric patients (aged ≤18 years) who received liver transplantation at Tianjin First Central Hospital in China between January 1, 2014 and December 31, 2018', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who received a liver transplant for the first time.\n* Patients who were younger than 18 years of age at the time of transplant.\n\nExclusion Criteria:\n\n* Patients with incomplete clinical data.\n* Patients with less than 5 years of follow-up.\n* Patients who have combined multiple solid organ transplants.\n* Patients with preoperative renal impairment (eGFR\\<60ml/min/1.73 m2 or prior renal replacement therapy).'}, 'identificationModule': {'nctId': 'NCT06598228', 'briefTitle': 'Acute Kidney Injury and Recovery Mode in Pediatric Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin First Central Hospital'}, 'officialTitle': 'Acute Kidney Injury and Recovery Mode in Pediatric Liver Transplantation', 'orgStudyIdInfo': {'id': '20240903-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'the group without acute kidney injury', 'description': 'Patients not diagnosed with acute kidney injury according to KDIGO(Kidney Disease: Improving Global Outcomes) criteria', 'interventionNames': ['Other: No Intervention: Observational Cohort']}, {'label': 'the group with transient acute kidney injury', 'description': 'Patients diagnosed with acute kidney injury according to KDIGO(Kidney Disease: Improving Global Outcomes) criteria and recovered within 48h', 'interventionNames': ['Other: No Intervention: Observational Cohort']}, {'label': 'the group with persistent acute kidney injury', 'description': 'Patients diagnosed with acute kidney injury according to KDIGO(Kidney Disease: Improving Global Outcomes) criteria and sustained over 48h', 'interventionNames': ['Other: No Intervention: Observational Cohort']}], 'interventions': [{'name': 'No Intervention: Observational Cohort', 'type': 'OTHER', 'description': 'no intervention', 'armGroupLabels': ['the group with persistent acute kidney injury', 'the group with transient acute kidney injury', 'the group without acute kidney injury']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tianjin', 'country': 'China', 'facility': 'Tianjin First Central Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin First Central Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the pediatric organ transplant unit', 'investigatorFullName': 'Wei Gao', 'investigatorAffiliation': 'Tianjin First Central Hospital'}}}}