Viewing Study NCT05666232


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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: Mansoura University
Organization:

Study Overview

Official Title: Renal Resistive Index and Myocardial Performance Index for Early Prediction of Acute Kidney Injury After Living Donor Liver Transplantation
Status: UNKNOWN
Status Verified Date: 2022-12
Last Known Status: NOT_YET_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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.

Aim 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.

Study design: a prospective observational study that will be conducted at Liver Transplantation Unit at Mansoura University on 105 consecutive living donor liver transplant recipients.

Methods: 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.
Detailed Description: 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.

The 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.

This 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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: