Renal and Cardiac Risk Factors of AKI After Liver Transplantation

NCT05666232 | Unknown

• 1 other identifier: MD.22.09.699
• Study Type: observational
• Target: 105
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• stage of AKI

  in the early 48 postoperative hours

• late AKI

  within 7 days

• length of ICU stay

  3 months after transplant

• length of hospital stay

  3 months after transplant

• three-month mortality

  3 months after transplantation

Interventions

renal resistive index and myocardial performance index DIAGNOSTIC_TEST

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.

Also known as: echocardiography, ultrasonography

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• patients undergoing right-lobe living-donor liver transplantation

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

MeSH Terms

Conditions

Acute Kidney Injury; Hypersensitivity

Interventions

Echocardiography; Ultrasonography

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Amr Yassen, MD

  Mansoura University Hospital

  STUDY CHAIR

Central Study Contacts

Ahmed Ali El-din, MSc

CONTACT

1288045390; ahmedalieldin2000@gmail.com

Moataz M Emara, MD, EDAIC

CONTACT

1064048848; mm.emara@mans.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2022
• First Posted: December 27, 2022
• Study Start: January 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: April 1, 2024
• Last Updated: December 27, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: within 3 months