Clinical trial NCT05666232: Renal and Cardiac Risk Factors of AKI After Liver Transplantation
Official title: Renal Resistive Index and Myocardial Performance Index for Early Prediction of Acute Kidney Injury After Living Donor Liver Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Kidney Injury
Acute Renal Injury
Liver Transplant; Complications
Keywords: 2-D Echocardiography
Two-Dimensional Echocardiography
renal resistive index
myocardial performance index
diagnostie test accuracy
sensitivity and specificity
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing living donor liver transplantation at gastrointestinal surgery center at Mansoura University - Mansoura, Egypt.

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.

Eligibility criteria: 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

Primary outcomes:
measure: early acute kidney injury (AKI)
timeFrame: in the early 48 postoperative hours
Secondary outcomes:
measure: stage of AKI
timeFrame: in the early 48 postoperative hours
measure: late AKI
timeFrame: within 7 days
measure: length of ICU stay
timeFrame: 3 months after transplant
measure: length of hospital stay
timeFrame: 3 months after transplant
measure: three-month mortality
timeFrame: 3 months after transplantation
measure: delayed renal function
timeFrame: 3 months after transplantation
Other outcomes:
Locations:
Study officials:
affiliation: Mansoura University Hospital
name: Amr Yassen, MD
role: STUDY_CHAIR
References: