NCT02080065

Brief Summary

The incidence of acute kidney injury after liver transplantation has been reported to be 17 to 95 percent, but no definite treatment has been reported yet. Therefore, it is important to identify and prevent reversible risk factors for acute kidney injury after liver transplantation. Previous studies have reported several preoperative clinical risk factors, but preoperative medication and intraoperative colloid administration and hemodynamic parameters have not been evaluated. Therefore, we attempt to evaluate perioperative risk factors and develop simplified clinical risk scoring model.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
573

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

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 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

August 28, 2015

Status Verified

August 1, 2015

Enrollment Period

1.4 years

First QC Date

March 4, 2014

Last Update Submit

August 27, 2015

Conditions

Keywords

risk factoracute kidney injuryliver transplantationpostoperative renal function

Outcome Measures

Primary Outcomes (1)

  • acute kidney injury as defined by RIFLE criteria

    acute kidney injury as defined by RIFLE criteria

    during 7 days after transplantation

Secondary Outcomes (4)

  • incidence of renal replacement therapy

    during one month after transplantation

  • incidence of acute rejection of graft

    during one month after transplantation

  • incidence of initial poor graft function

    during one month after transplantation

  • incidence of retransplantation

    during one month after transplantation

Other Outcomes (1)

  • Mortality

    during one month, six month, one year

Study Arms (1)

liver transplantation

patients who underwent living donor liver transplantation during between 2007 and 2013

Procedure: living donor liver transplantation

Interventions

liver transplantation

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients who underwent living donor liver transplantation between 2010 and 2013

You may qualify if:

  • Patients who underwent living donor liver transplantation between 2010 and 2013 in Samsung Medical Center

You may not qualify if:

  • Incomplete data regarding pre- and postoperative creatinine and estimated Glomerular Filtration Rate
  • patient who underwent retransplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

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

Study Record Dates

First Submitted

March 4, 2014

First Posted

March 6, 2014

Study Start

January 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

August 28, 2015

Record last verified: 2015-08

Locations