Antithrombin III and Post-liver Transplantation Acute Kidney Injury

May 30, 2021 updated by: Kyoung-Sun Kim, Asan Medical Center

Low Preoperative Antithrombin III Level is Associated With Postoperative Acute Kidney Injury After Liver Transplantation

The reno-protective effect of Antithrombin III (ATIII) has been well-studied in various animal studies; however, little is known about the effect of ATIII on kidney function in patients undergoing liver transplantation (LT). This study aimed to determine the association between preoperative ATIII level and postoperative acute kidney injury (AKI) after LT (post-LT AKI).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2395

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

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients who underwent either living- or deceased-donor LT (LDLT, DDLT) from January 2010 to January 2018 in Asan Medical Center.

Description

Inclusion Criteria:

  • patients who underwent either living- or deceased-donor LT (LDLT, DDLT) from January 2010 to January 2018

Exclusion Criteria:

  • patients who underwent re-transplantation
  • patients who were previously diagnosed with end-stage renal disease or Chronic kidney disease
  • patients who were being treated with continuous renal replacement therapy
  • preoperative or postoperative Antithrombin III levels were not available

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

  • Observational Models: Case-Control
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
antithrombin III < 50 %
preoperative antithrombin III levels <50%
Drug: Antithrombin III
In liver transplant recipients with baseline antithrombin III levels lower than 50%, exogenous Antithrombin III was administrated during the anhepatic phase of the liver transplant surgery.
Antithrombin III ≥ 50 %
preoperative antithrombin III levels ≥ 50 %

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
acute kidney injury
Time Frame: postoperative 7 day
serum creatinine >0.3 mg/dL within POD 2 or increase by >1.5 times within POD 7 according to the criteria set by the Kidney Disease: Improving Global Outcomes (KDIGO) classification
postoperative 7 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
chronic kidney disease
Time Frame: postoperative 3 months
glomerular filtration rate less than 60 mL∙min-1∙1.73m-2 on two consecutive occasions at least 3 months apart
postoperative 3 months
early allograft dysfucion
Time Frame: postoperative 7 day
at least one of the following: total bilirubin ≥10 mg/dL on postoperative day (POD) 7, prothrombin time (INR) ≥1.6 on POD 7, and alanine or aspartate aminotransferases >2000 IU/L within POD 7
postoperative 7 day

Collaborators and Investigators

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

Sponsor

Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 4, 2010

Primary Completion (Actual)

January 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

May 30, 2021

First Submitted That Met QC Criteria

May 30, 2021

First Posted (Actual)

June 3, 2021

Study Record Updates

Last Update Posted (Actual)

June 3, 2021

Last Update Submitted That Met QC Criteria

May 30, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-1699

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Time Frame

starting 6 months after publication

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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