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OpenTrials
Completed

NCT Number: NCT04912193

Antithrombin III and Post-liver Transplantation Acute Kidney Injury

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).

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Key information

Conditions

Liver Transplantation and Antithrombin Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Asan Medical Center

Seoul, 05507, South Korea

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antithrombin III

Drug

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2019
Study completion
2019
First posted
Jun 3, 2021
Registry last updated
Jun 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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