Renal and Cardiac Risk Factors of AKI After Liver Transplantation

Not yet recruiting

• Conditions: Liver Transplant; Complications; Acute Kidney Injury; Acute Renal Injury

• Registration Number: NCT05666232
• Lead Sponsor: Mansoura University

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 Timeline

• Status Verified: 2022-12
• Study First Submitted: 2022-12-18
• Study First Submitted QC: 2022-12-23
• Last Update Submitted: 2022-12-23
• Study First Posted: 2022-12-27
• Last Update Posted: 2022-12-27
• Study Start: 2023-01
• Primary Completion: 2024-01
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 105

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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.
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