Clinical trial NCT03530761: Korean Cohort Study of AKI & HRS in Cirrhosis
Official title: Kidney Biomarkers for the Prediction of Response to Terlipressin and Survival in Cirrhotic Patients With Acute Kidney Injury: Multicenter, Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Cirrhosis
Acute Kidney Injury
Hepatorenal Syndrome
Lead sponsor: Soonchunhyang University Hospital
Sponsor class: OTHER
First posted: 2018-05-21
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with liver cirrhosis diagnosed as acute kidney injury or hepatorenal syndrome

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: up to 3 years
Secondary outcomes:
measure: Transplantation free survival
timeFrame: up to 3 years
measure: Regression of acute kidney injury
timeFrame: up to 1 month
measure: Recurrence of acute kidney injury
timeFrame: up to 1 year
measure: Progression to chronic kidney disease
timeFrame: 1 year
measure: Response rate to terlipressin
timeFrame: 1 week
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: SoonChunHyang University Bucheon Hospital
state: Gyeonggi Do
Study officials:
affiliation: Soonchunhyang University Hospital
name: Jeong-Ju Yoo, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
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