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Antithrombin III and Post-liver Transplantation Acute Kidney Injury

Sponsor
Asan Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT04912193
Collaborator
(none)
2,395
Enrollment
1
Location
119.9
Actual Duration (Months)
20
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Antithrombin III

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
2395 participants
Observational Model:
Case-Control
Time Perspective:
Other
Official Title:
Low Preoperative Antithrombin III Level is Associated With Postoperative Acute Kidney Injury After Liver Transplantation
Actual Study Start Date :
Jan 4, 2010
Actual Primary Completion Date :
Jan 31, 2019
Actual Study Completion Date :
Dec 31, 2019

Arms and Interventions

Arm 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 %

Outcome Measures

Primary Outcome Measures

  1. acute kidney injury [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

Secondary Outcome Measures

  1. chronic kidney disease [postoperative 3 months]

    glomerular filtration rate less than 60 mL∙min-1∙1.73m-2 on two consecutive occasions at least 3 months apart

  2. early allograft dysfucion [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Asan Medical Center Seoul Korea, Republic of 05507

Sponsors and Collaborators

  • Asan Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Kyoung-Sun Kim, Senior Clinical Fellow, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT04912193
Other Study ID Numbers:
  • 2019-1699
First Posted:
Jun 3, 2021
Last Update Posted:
Jun 3, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Keywords provided by Kyoung-Sun Kim, Senior Clinical Fellow, Asan Medical Center
acute kidney injury
antithrombins
liver transplantation
Additional relevant MeSH terms:
Acute Kidney Injury
Antithrombins
Antithrombin III

Study Results

No Results Posted as of Jun 3, 2021