NCT06320730

Brief Summary

This retrospective cohort study of patients classified by the blood glucose level after reperfusion in liver transplantation repicient. Our object is to investigate whether controlling BG levels within the optimal range during neohepatic phase is associated with a reduction of AKI incidence. Furthermore, severe AKI, chronic kidney disease (CKD), major adverse cardiac event (MACE) and mortality were also investigated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,790

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Shorter than P25 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

August 25, 2020

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 20, 2024

Completed
Last Updated

March 20, 2024

Status Verified

March 1, 2024

Enrollment Period

4 days

First QC Date

March 8, 2024

Last Update Submit

March 19, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • incidence of 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 (4)

  • incidence of severe AKI

    within 7 days after surgery

  • incidence of chronic kidney disease (CKD)

    within 1 year after surgery

  • incidence of Major adverse cardiac event (MACE)

    within postoperative 30 days (POD30)

  • overall mortality

    the mortality 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)

Group 110 < REP BG < 180

Those with blood glucose levels over 110 and under 180 after reperfusion in liver transplantation recipients.

Other: Observational study, records of blood glucose level after reperfusion

Group REP BG ≤110 or ≥180

Those with blood glucose levels below 110 or above 180 after reperfusion in liver transplantation recipients.

Interventions

Analyzes blood glucose level after reperfusion by dividing it into two groups: those with blood glucose levels between 110 and 180 and those with blood glucose levels below 110 or above 180.

Group 110 < REP BG < 180

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 transplant recipients at Asan Medical Center, Seoul, Korea, Republic of Korea, from January 2008 to December 2019.

You may qualify if:

  • Living donor liver transplantation recipients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jun-Gol Song

Seoul, Song-pa Gu, 05500, South Korea

Location

MeSH Terms

Conditions

Acute Kidney InjuryHyperglycemiaHypoglycemiaEnd Stage Liver Disease

Interventions

Observation

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesLiver FailureHepatic InsufficiencyLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

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 8, 2024

First Posted

March 20, 2024

Study Start

August 25, 2020

Primary Completion

August 29, 2020

Study Completion

March 1, 2021

Last Updated

March 20, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations