Korean Cohort Study of AKI & HRS in Cirrhosis

• Conditions: Liver Cirrhosis; Acute Kidney Injury; Hepatorenal Syndrome

• Registration Number: NCT03530761
• Lead Sponsor: Soonchunhyang University Hospital

Brief Summary

The aim of this study is to investigate i) whether two biomarkers (urine NAG, urinary cystatin C) could be predictive factor in patient with liver cirrhosis, , and ii) whether these biomarkers can predict response of terlipressin.

Detailed Description

Acute kidney injury (AKI) in patients with liver cirrhosis is sometimes accompanied by tubular injury which can lead to poor outcome. Current AKI criteria using serum creatinine (Cr) has some limitations to predict reversibility of renal function and discriminate renal parenchymal injury in cirrhotic patients. The aim of this study is to evaluate whether urine biomarkers \[cystatin C, N-acetyl-β-D-Glucosaminidase (NAG)\] can predict survival and response to terlipressin in cirrhotic patients with AKI.

Study Timeline

• Study Start: 2017-08-01
• Study First Submitted: 2018-04-25
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-08
• Last Update Submitted: 2018-05-08
• Study First Posted: 2018-05-21
• Last Update Posted: 2018-05-21
• Primary Completion: 2018-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 245

Inclusion Criteria

• Patients with liver cirrhosis diagnosed as acute kidney injury or hepatorenal syndrome
• Patients who voluntarily agreed to the study

Exclusion Criteria

• Patients with active bleeding (eg, varix bleeding) within 7 days
• Patients with hepatocellular carcinoma
• Patients with hypersensitivity to terlipressin
• Patients with anuria
• Pregnant and lactating patients
• Patients who did not agree with the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	up to 3 years	From date of sample collection until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years

Secondary Outcome Measures

Name	Time	Method
Transplantation free survival	up to 3 years	From date of sample collection until the date of first liver transplantation or date of death from any cause, whichever came first, assessed up to 3 years
Regression of acute kidney injury	up to 1 month	Regression is defined as movement of AKI to a lower stage and decrease of serum creatinine
Recurrence of acute kidney injury	up to 1 year	From sample collection day to elevation day of creatinine
Progression to chronic kidney disease	1 year	From sample collection day to progression to CKD
Response rate to terlipressin	1 week	If reduction of creatinine 0.3mg/dL from the baseline

Trial Locations

Locations (1)

SoonChunHyang University Bucheon Hospital; 🇰🇷 Bucheon, Gyeonggi Do, Korea, Republic of