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NCT06340607 Clinical Trial

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

Acute Kidney Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06340607
Other study ID # 2023-0561
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 5, 2012
Est. completion date December 31, 2022

Study information
Verified date March 2024
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 3422
Est. completion date December 31, 2022
Est. primary completion date January 5, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Asan Medical Center Seoul Song-pa Gu

Sponsors (1)
Lead Sponsor Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 chronic kidney injury 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
Secondary graft failure 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)]
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