Development and Validation of a Clinical Risk Prediction Model for Early Acute Kidney Injury Within 48 Hours After Liver Transplantation

December 20, 2024 updated by: Beijing Tsinghua Chang Gung Hospital

Development and Validation of a Clinical Risk Prediction Model for Early Acute Kidney Injury After Liver Transplantation

Acute kidney injury (AKI) is a common complication after liver transplantation, with an incidence of 12.7-95%. The occurrence of acute kidney injury after transplantation is related to the poor prognosis of patients, which significantly increases the length of hospital stay, hospitalization costs and mortality of patients. Early recognition of acute kidney injury after transplantation is of great significance. Therefore, by collecting preoperative and intraoperative variables, this study intends to establish and verify a clinical risk prediction model for early AKI after liver transplantation, in order to provide clinicians with a visual prediction tool to identify patients with high risk of early AKI after liver transplantation immediately after the operation, so as to start clinical intervention as soon as possible and improve the prognosis of patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

453

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Province
      • Beijing, Province, China, 102218
        • Beijing Tsinghua Changgung Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Inclusion criteria for our study comprised consecutive patients undergoing liver transplantation at Tsinghua University Beijing Changgung Hospital from January 1, 2018, to October 15, 2022. Exclusion criteria were as follows: (1) under 18 years of age (2) post-renal transplant (3) liver combined with other organ transplants (4) preoperative requirement for renal replacement therapy (RRT) (5) patients with second or multiple liver transplants (6) preoperative estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2, and (7) patients with severe illness leading to termination of surgery.

Description

Inclusion Criteria:

  • patients who underwent liver transplantation in Beijing Tsinghua Changgung Hospital.

Exclusion Criteria:

  • (1) under 18 years of age (2) post-renal transplant (3) liver combined with other organ transplants (4) preoperative requirement for renal replacement therapy (RRT) (5) patients with second or multiple liver transplants (6) preoperative estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2, and (7) patients with severe illness leading to termination of surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AKI group
Participants who were diagnosed acute kidney injury(AKI)
Diagnostic test: KDIGO CRITERIA
2012 KDIGO DIAGNOSTIC CRITERIA
Non-AKI group
Participants who were not diagnosed AKI
Diagnostic test: KDIGO CRITERIA
2012 KDIGO DIAGNOSTIC CRITERIA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
KDIGO criteria (Kidney Disease: Improving Global Outcomes) used to evaluate postoperative AKI in liver transplant patients.
Time Frame: 48 hours post-surgery
Diagnosed according to 2012 KDIGO criteria: serum creatinine rise ≥50% or ≥26.5 µmol/L within 48 hours post-surgery. Baseline creatinine was the most recent preoperative value, with kidney function assessed by eGFR.
48 hours post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tsinghua Chang Gung Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

October 15, 2022

Study Completion (Actual)

December 15, 2022

Study Registration Dates

First Submitted

December 20, 2024

First Submitted That Met QC Criteria

December 20, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 20, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22216-4-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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