NCT06340607

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,422

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2012

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2020

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 1, 2024

Completed
Last Updated

April 1, 2024

Status Verified

March 1, 2024

Enrollment Period

8 years

First QC Date

March 25, 2024

Last Update Submit

March 25, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • acute kidney injury

    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 Outcomes (2)

  • chronic kidney injury

    within 1 year after surgery

  • 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)]

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • living donor liver transplantation recipients (≥18 years)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, Song-pa Gu, 05500, South Korea

Location

MeSH Terms

Conditions

Acute Kidney InjuryRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 25, 2024

First Posted

April 1, 2024

Study Start

January 5, 2012

Primary Completion

January 5, 2020

Study Completion

December 31, 2022

Last Updated

April 1, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations