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

NCT06750770 | Completed DMC

• 1 other identifier: 22216-4-01
• Study Type: observational
• Target: 453
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Kidney Injury; Liver Transplantation; Model

Keywords

acute kidney injury, liver transplantation, model, validation

Outcome Measures

Primary Outcomes (1)

• KDIGO criteria (Kidney Disease: Improving Global Outcomes) used to evaluate postoperative AKI in liver transplant patients.

  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

Study Arms (2)

AKI group

Participants who were diagnosed acute kidney injury(AKI)

Diagnostic Test: KDIGO CRITERIA

Non-AKI group

Participants who were not diagnosed AKI

Diagnostic Test: KDIGO CRITERIA

Interventions

KDIGO CRITERIA DIAGNOSTIC_TEST

2012 KDIGO DIAGNOSTIC CRITERIA

AKI group; Non-AKI group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• (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.

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

Study Sites (1)

Beijing Tsinghua Changgung Hospital

Beijing, Province, 102218, China

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 27, 2024
• Study Start: January 1, 2018
• Primary Completion: October 15, 2022
• Study Completion: December 15, 2022
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)