Neohepatic Albumin-Bilirubin Scores on Renal Outcomes in Living-donor Liver Transplantation Recipients

March 25, 2024 updated by: Jun-Gol Song, Asan Medical Center

Impact of Neohepatic Albumin-Bilirubin Scores on Renal Outcomes Following Living-donor Liver Transplantation: Propensity Score Analysis

This study investigates the association between post-reperfusion (neohepatic) ALBI scores and post-LT renal outcomes in living-donor LT (LDLT) recipients.

Study Overview

Status

Completed

Conditions

Detailed Description

Acute kidney injury (AKI) after liver transplantation (LT) significantly affects patient and graft outcomes. The Albumin-Bilirubin (ALBI) score, an objective and sensitive index of liver function, has potential applicability in predicting outcomes following LT. This study investigates the association between post-reperfusion (neohepatic) ALBI scores and post-LT renal outcomes in living-donor LT (LDLT) recipients.

Study Type

Observational

Enrollment (Actual)

3422

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

  • Korea, Republic of
    • Song-pa Gu
      • Seoul, Song-pa Gu, Korea, Republic of, 05500
        • Asan Medical Center

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

Non-Probability Sample

Study Population

living donor liver transplantation recipients at Asan Medical Center, Seoul, Korea from January 2012 to December 2019

Description

Inclusion Criteria:

  • living donor liver transplantation recipients (≥18 years)

Exclusion Criteria:

  • preoperative serum creatinine (sCr) > 1.4 mg/dL, diagnosed CKD or hepatorenal syndrome (HRS), or hemodialysis at baseline

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
Recipients with neohepatic ALBI ≥ -1.615
The ALBI score was calculated using the formula: (log10bilirubin × 0.66) + (albumin × -0.085), where bilirubin is measured in μmol/L and albumin in g/L. Recipients with neohepatic (post-reperfusion) ALBI ≥ -1.615
Recipients with neohepatic ALBI < -1.615
Recipients with neohepatic (post-reperfusion) ALBI < -1.615

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
acute kidney injury
Time Frame: within 7 days after surgery
determined by change in sCr according to the Kidney Disease: Improving Global Outcomes (KDIGO) definition (increase in sCr of ≥26.5 mmol litre-1 within 48h or ≥1.5 times baseline within 7 days after surgery
within 7 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
chronic kidney injury
Time Frame: within 1 year after surgery
when renal function assessed by calculating estimated serum glomerular filtration using the abbreviated modification of diet in renal disease equation was <60 mL/min/1.73 m2 for 3 months or more, irrespective of cause
within 1 year after surgery
graft failure
Time Frame: the graft failure at overall period (calculated from the date of surgery to the last follow-up) from the date of surgery (up to 10 years)]
graft failure
the graft failure at overall period (calculated from the date of surgery to the last follow-up) from the date of surgery (up to 10 years)]

Collaborators and Investigators

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

Sponsor

Asan Medical Center

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 5, 2012

Primary Completion (Actual)

January 5, 2020

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

March 25, 2024

First Submitted That Met QC Criteria

March 25, 2024

First Posted (Actual)

April 1, 2024

Study Record Updates

Last Update Posted (Actual)

April 1, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-0561

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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