Renal and Cardiac Risk Factors of AKI After Liver Transplantation

Sponsor

Mansoura University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05666232

Collaborator

(none)

105

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury Acute Renal Injury Liver Transplant; Complications	Diagnostic Test: renal resistive index and myocardial performance index

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 Design

Study Type:

Observational

Anticipated Enrollment :

105 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Renal Resistive Index and Myocardial Performance Index for Early Prediction of Acute Kidney Injury After Living Donor Liver Transplantation

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Apr 1, 2024

Outcome Measures

Primary Outcome Measures

early acute kidney injury (AKI) [in the early 48 postoperative hours]
international Club of Ascites' revised classification of AKI in cirrhotic patients as a 0.3 mg/kg increase in serum creatinine

Secondary Outcome Measures

stage of AKI [in the early 48 postoperative hours]
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.
late AKI [within 7 days]
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
length of ICU stay [3 months after transplant]
duration of ICU stay (days) in survived patients
length of hospital stay [3 months after transplant]
duration of ICU stay (days) in survived patients
three-month mortality [3 months after transplantation]
all-cause mortality
delayed renal function [3 months after transplantation]
serum creatinine

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

patients undergoing right-lobe living-donor liver transplantation

Exclusion Criteria:

preoperative renal impairment (GFR < 60 ml/min/1.73 m2)
known renal artery stenosis
patient who underwent previous nephrectomy
ischemic heart disease (patient who takes anti-ischemic measures as prescribed by a consultant cardiologist)
Patient with arrthymia or who develop persistent intraoperative arrythmia