Ignite Creation Date:
2025-12-24 @ 9:37 PM
Ignite Modification Date:
2025-12-27 @ 5:58 AM
Study NCT ID:
NCT05666232
Status:
UNKNOWN
Last Update Posted:
2022-12-27
First Post:
2022-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Renal and Cardiac Risk Factors of AKI After Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D006967', 'term': 'Hypersensitivity'}], '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'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004452', 'term': 'Echocardiography'}, {'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 105}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-23', 'studyFirstSubmitDate': '2022-12-18', 'studyFirstSubmitQcDate': '2022-12-23', 'lastUpdatePostDateStruct': {'date': '2022-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'early acute kidney injury (AKI)', 'timeFrame': 'in the early 48 postoperative hours', 'description': "international Club of Ascites' revised classification of AKI in cirrhotic patients as a 0.3 mg/kg increase in serum creatinine"}], 'secondaryOutcomes': [{'measure': 'stage of AKI', 'timeFrame': 'in the early 48 postoperative hours', 'description': 'Stage (1): serum creatinine increase 1.5- 1.9 times base line; or serum creatinine increase more than 0.3mg/dl. Stage (2): serum creat. Increase 2-2.9 times baseline. Stage (3): serum creat. Increase 3 times baseline ; or s.creat increase to 4mg/dl; or initiation of renal replacement therapy.'}, {'measure': 'late AKI', 'timeFrame': 'within 7 days', 'description': "International Club of Ascites' revised classification of AKI in cirrhotic patients as a 0.3 mg/kg increase in serum creatinine or \\>= 50% increase in the basal serum creatinine"}, {'measure': 'length of ICU stay', 'timeFrame': '3 months after transplant', 'description': 'duration of ICU stay (days) in survived patients'}, {'measure': 'length of hospital stay', 'timeFrame': '3 months after transplant', 'description': 'duration of ICU stay (days) in survived patients'}, {'measure': 'three-month mortality', 'timeFrame': '3 months after transplantation', 'description': 'all-cause mortality'}, {'measure': 'delayed renal function', 'timeFrame': '3 months after transplantation', 'description': 'serum creatinine'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['2-D Echocardiography', 'Two-Dimensional Echocardiography', 'renal resistive index', 'myocardial performance index', 'diagnostie test accuracy', 'sensitivity and specificity'], 'conditions': ['Acute Kidney Injury', 'Acute Renal Injury', 'Liver Transplant; Complications']}, 'descriptionModule': {'briefSummary': 'Background: Liver transplantation (LT) is an extensive operation with various factors contributing to the development of acute kidney injury in the perioperative period. Early diagnosis of AKI can improve clinical outcomes in LT recipients. Renal resistive index is measured in renal arteries and high resistive values are associated with more adverse cardiovascular events and renal failure progression. Myocardial performance index reflects overall cardiac function rather than systolic or diastolic function alone.\n\nAim of the study: to investigate whether combined doppler renal resistive index and myocardial performance index could predict early postoperative acute kidney injury in living donor liver transplant recipients.\n\nStudy design: a prospective observational study that will be conducted at Liver Transplantation Unit at Mansoura University on 105 consecutive living donor liver transplant recipients.\n\nMethods: Renal resistive index (assessed by transabdominal ultrasound) and myocardial performance index (assessed by transthoracic echocardiography) will be measured just before operation, on termination of operation and then daily in the intensive care unit for 7 days. Patients will be observed for development of acute kidney injury.', 'detailedDescription': 'This study aims to investigate whether combined doppler renal resistive index (RRI) assessed by transabdominal sonography and myocardial performance index (MPI) assessed by transthoracic echocardiography could predict early postoperative acute kidney injury in living donor liver transplant recipients.\n\nThe primary outcome is the predictive value of renal resistive index and myocardial performance index for the onset of early post living donor liver transplant acute kidney injury.\n\nThis prospective observational study will be conducted at Liver Transplantation Unit at Mansoura University from November 2022 till fulfillment of sample size after obtaining approval from Institutional Review Board (IRB). One hundred and five consecutive LDLT recipients will participate in this study after obtaining informed consents. They will be observed for the development of early postoperative acute kidney injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients undergoing living donor liver transplantation at gastrointestinal surgery center at Mansoura University - Mansoura, Egypt.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing right-lobe living-donor liver transplantation\n\nExclusion Criteria:\n\n* preoperative renal impairment (GFR \\< 60 ml/min/1.73 m2)\n* known renal artery stenosis\n* patient who underwent previous nephrectomy\n* ischemic heart disease (patient who takes anti-ischemic measures as prescribed by a consultant cardiologist)\n* Patient with arrthymia or who develop persistent intraoperative arrythmia'}, 'identificationModule': {'nctId': 'NCT05666232', 'briefTitle': 'Renal and Cardiac Risk Factors of AKI After Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Renal Resistive Index and Myocardial Performance Index for Early Prediction of Acute Kidney Injury After Living Donor Liver Transplantation', 'orgStudyIdInfo': {'id': 'MD.22.09.699'}}, 'armsInterventionsModule': {'interventions': [{'name': 'renal resistive index and myocardial performance index', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['echocardiography', 'ultrasonography'], 'description': 'Transthoracic echocardiography and transabdominal ultrasonography will be performed before induction of anesthesia, after termination of operation and before transmission to ICU and then daily for the early seven postoperative days.\n\nRRI = (peak systolic velocity - end diastolic velocity) ∕ peak systolic velocity: Then, we will obtain the mean RRI from the above three measurements.\n\nWe will consider RRI ≥0.7 as abnormal and define it as subclinical AKI.\n\nMyocardial performance index (using tissue doppler) =\n\n(isovolumetric contraction time + isovolumetric relaxation time) / ejection time. We will consider MPI ≥0.4 as abnormal and define it as subclinical LV dysfunction.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ahmed Ali El-din, MSc', 'role': 'CONTACT', 'email': 'ahmedalieldin2000@gmail.com', 'phone': '1288045390', 'phoneExt': '+20'}, {'name': 'Moataz M Emara, MD, EDAIC', 'role': 'CONTACT', 'email': 'mm.emara@mans.edu.eg', 'phone': '1064048848', 'phoneExt': '+20'}], 'overallOfficials': [{'name': 'Amr Yassen, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Mansoura University Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'within 3 months', 'ipdSharing': 'YES', 'description': 'The anonymized patient data will be available on reasonable request after approval of the local IRB.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}