Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-27 @ 11:42 PM
Study NCT ID:
NCT06123260
Status:
UNKNOWN
Last Update Posted:
2023-11-08
First Post:
2023-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Renal Outcomes Among Post Liver Transplantation Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007677', 'term': 'Kidney Function Tests'}], 'ancestors': [{'id': 'D003950', 'term': 'Diagnostic Techniques, Urological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-07', 'studyFirstSubmitDate': '2023-11-02', 'studyFirstSubmitQcDate': '2023-11-07', 'lastUpdatePostDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'calculation the incidence of AKI in Liver transplantation patients', 'timeFrame': 'Baseline', 'description': 'Determination of the most common risk factor for AKI in liver transplantation patients.'}], 'secondaryOutcomes': [{'measure': 'mortality rate', 'timeFrame': 'Baseline', 'description': 'patient survival in post LT AKI group.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Transplant; Complications', 'Renal Complication of Procedure']}, 'referencesModule': {'references': [{'pmid': '101682', 'type': 'BACKGROUND', 'citation': 'Feffer SE, Parray HR, Westring DW. Seizure after infusion of aminocaproic acid. JAMA. 1978 Nov 24;240(22):2468. No abstract available.'}, {'pmid': '498506', 'type': 'BACKGROUND', 'citation': 'Rautela GS, Snee RD, Miller WK. Response-surface co-optimization of reaction conditions in clinical chemical methods. Clin Chem. 1979 Nov;25(11):1954-64.'}, {'pmid': '16531664', 'type': 'BACKGROUND', 'citation': 'Ramakrishnan R, Mittal S, Ambatkar S, Kader MA. Retinal nerve fibre layer thickness measurements in normal Indian population by optical coherence tomography. Indian J Ophthalmol. 2006 Mar;54(1):11-5. doi: 10.4103/0301-4738.21608.'}, {'pmid': '574584', 'type': 'BACKGROUND', 'citation': "Braun OH, Kreipe U. [Rare forms of chronic osteomyelitis in children (author's transl)]. Klin Padiatr. 1979 Sep;191(5):511-21. German."}, {'pmid': '736749', 'type': 'BACKGROUND', 'citation': 'Pannuti F. Surgical adjuvant hormone therapy in breast cancer. Arch Geschwulstforsch. 1978;48(7):680-2. No abstract available.'}, {'pmid': '595602', 'type': 'BACKGROUND', 'citation': "Pozenel H. [The influence of mexiletin on ventricular arrhythmias during ergometric exercise (author's transl)]. Wien Klin Wochenschr. 1977 Dec 9;89(23):783-8. German."}, {'pmid': '870880', 'type': 'BACKGROUND', 'citation': 'Blom E. A decapitated sperm defect in two sterile Hereford bulls. Nord Vet Med. 1977 Mar;29(3):119-23.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate Renal outcomes among patients, post liver transplantation at Assiut university.', 'detailedDescription': 'It is estimated that 1 in 4 liver transplantation (LT) recipients has an estimated glomerular filtration rate (eGFR) of \\<60mL/minute/1.73 m2 at the time of LT Renal dysfunction, both before or after LT, is an important comorbidity associated with an increased risk of death, morbidity, and cost. Serum creatinine, a major component of the Model for End-Stage Liver Disease (MELD) score, has driven the increased incidence of renal dysfunction among patients undergoing LT End-stage liver disease (ESLD) is commonly complicated by kidney dysfunction, which in turn leads to a worse prognosis. The kidney dysfunction can be functional or structural, ranging from prerenal azotemia and hepatorenal syndrome causing acute kidney injury to immunoglobulin A (IgA) nephropathy (IgAN) and membranoproliferative glomerulonephritis causing chronic kidney disease Each condition carries a different presentation, treatment, prognosis, and risk of recurrence. Therefore, when ESLD patients undergo evaluation for liver transplant, it is critical to assess their kidney function and understand the cause of any underlying kidney dysfunction LT recipients will continue to worsen due to calcineurin inhibitor toxicity and lack of recovery from hepatorenal syndrome (HRS), necessitating renal replacement therapy Patients who are not expected to recover their kidney function after liver transplant usually benefit from combined liver and kidney transplant (CLKT). Others may need modified immunosuppressive regimens that minimize or avoid use of calcineurin inhibitors to preserve the remaining kidney function.\n\nFor assessment of kidney function, Equations that estimate GFR are most commonly used in daily practice. They have the advantage of being inexpensive and results are immediately available. Their disadvantage is that they rely on endogenous biomarkers, which are confounded by non-GFR determinants such as age, sex, muscle mass, drugs, certain chronic conditions, diet and presumably many more Creatinine, the most commonly used biomarker, depends heavily on muscle mass. Pre and intraoperative factors and postoperative complications were evaluated for their impact on development of AKI The preoperative factors MELD, SCr, Bilirubin and INR were highly associated with an increased risk for developing AKI requiring RRT for the post OLT complications, length of ICU stay was associated with the development of AKI Patients with a longer ventilation time and a higher amount of RPC transfusion were more likely to have AKI requiring RRT, whereas these parameters were not associated with milder forms of AKI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'retrospective cohort study will be done to patients post liver transplantation at El Raghy university hospital', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Data of all Patients underwent liver transplants with their reports available at El Raghy university hospital\n\nExclusion Criteria:\n\n* Inadequate data\n* Patients on dialysis more than 8 weeks pre liver transplant.'}, 'identificationModule': {'nctId': 'NCT06123260', 'briefTitle': 'Renal Outcomes Among Post Liver Transplantation Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Short Term Renal Outcomes Among Post Liver Transplantation Patients at Assiut University', 'orgStudyIdInfo': {'id': 'renal outcomes post OLT'}}, 'armsInterventionsModule': {'interventions': [{'name': 'renal function tests', 'type': 'DIAGNOSTIC_TEST', 'description': 'BUN, eGFR , CBC , Electrolytes , Liver function tests'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ebram Magdy Eskander, M.B.B.Ch', 'role': 'CONTACT', 'email': 'ebrammagdy93@gmail.com', 'phone': '01116094001'}, {'name': 'Refaat Fathy Abd elaal, MD', 'role': 'CONTACT', 'email': 'refaatfathy21@yahoo.com', 'phone': '01011121526'}], 'overallOfficials': [{'name': 'Bahaa Osman Taha, Master', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bahaa_osman99@aun.edu.eg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'doctor', 'investigatorFullName': 'Ebram Magdy Eskander Nashed', 'investigatorAffiliation': 'Assiut University'}}}}