Renal and Cardiac Risk Factors of AKI After Liver Transplantation

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05666232
• Other study ID #: MD.22.09.699
• Status: Not yet recruiting
• Start date: January 2023
• Est. completion date: April 2024

Study information

• Verified date: December 2022
• Source: Mansoura University
• Contact: Ahmed Ali El-din, MSc
• Phone: 1288045390
• Email: ahmedalieldin2000[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 105
• Est. completion date: April 2024
• Est. primary completion date: January 2024
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Injury
• Liver Transplant; Complications
• Wounds and Injuries

Intervention

Diagnostic Test:
• renal resistive index and myocardial performance index
Transthoracic echocardiography and transabdominal ultrasonography will be performed before induction of anesthesia, after termination of operation and before transmission to ICU and then daily for the early seven postoperative days. RRI = (peak systolic velocity - end diastolic velocity) / peak systolic velocity: Then, we will obtain the mean RRI from the above three measurements. We will consider RRI =0.7 as abnormal and define it as subclinical AKI. Myocardial performance index (using tissue doppler) = (isovolumetric contraction time + isovolumetric relaxation time) / ejection time. We will consider MPI =0.4 as abnormal and define it as subclinical LV dysfunction.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	length of ICU stay	duration of ICU stay (days) in survived patients	3 months after transplant
Secondary	length of hospital stay	duration of ICU stay (days) in survived patients	3 months after transplant
Secondary	three-month mortality	all-cause mortality	3 months after transplantation
Secondary	delayed renal function	serum creatinine	3 months after transplantation