Renal and Cardiac Risk Factors of AKI After Liver Transplantation

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Kidney Injury; Liver Transplant; Complications; Acute Renal Injury
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 105

Contacts and Locations

• Study Contact: Name: Ahmed Ali El-din, MSc; Phone Number: +20 1288045390; Email: ahmedalieldin2000@gmail.com
• Study Contact Backup: Name: Moataz M Emara, MD, EDAIC; Phone Number: +20 1064048848; Email: mm.emara@mans.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing living donor liver transplantation at gastrointestinal surgery center at Mansoura University - Mansoura, Egypt.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Amr Yassen, MD, Mansoura University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: December 18, 2022
• First Submitted That Met QC Criteria: December 23, 2022
• First Posted (Actual): December 27, 2022

Study Record Updates

• Last Update Posted (Actual): December 27, 2022
• Last Update Submitted That Met QC Criteria: December 23, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: sensitivity and specificity; 2-D Echocardiography; Two-Dimensional Echocardiography; renal resistive index; myocardial performance index; diagnostie test accuracy
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: MD.22.09.699

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The anonymized patient data will be available on reasonable request after approval of the local IRB.
• IPD Sharing Time Frame: within 3 months
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No