Antithrombin III and Post-liver Transplantation Acute Kidney Injury

Completed

• Conditions: Liver Transplantation and Antithrombin
• Interventions: Drug: Antithrombin III

• Registration Number: NCT04912193
• Lead Sponsor: Asan Medical Center

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-04
• Primary Completion: 2019-01-31
• Study Completion: 2019-12-31
• Status Verified: 2021-05
• Study First Submitted: 2021-05-30
• Study First Submitted QC: 2021-05-30
• Last Update Submitted: 2021-05-30
• Study First Posted: 2021-06-03
• Last Update Posted: 2021-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2395

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
antithrombin III < 50 %	Antithrombin III	preoperative antithrombin III levels \<50%

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of