Korean Cohort Study of AKI & HRS in Cirrhosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Kidney Biomarkers for the Prediction of Response to Terlipressin and Survival in Cirrhotic Patients With Acute Kidney Injury: Multicenter, Prospective Cohort Study

Conditions
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Liver Cirrhosis, Acute Kidney Injury, Hepatorenal Syndrome

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acute kidney injury<br>Increase in serum creatinine more than 0.3 mg/dl within 48 hours or a percentage increase serum creatinine more than 50% from baseline. | |
| Hepatorenal syndrome<br>Diagnosis of cirrhosis and ascites, Diagnosis of AKI according to ICA-AKI criteria No response after 2 consecutive days of diuretic withdrawal and plasma volume expansion with albumin 1 g per kg of body weight Absence of shock No current or recent use of nephrotoxic drugs (non-steroidal anti-inflammatory drugs, aminoglycosides, iodinated contrast media, etc.) No macroscopic signs of structural kidney injury, defined as: absence of proteinuria (> 500 mg/day), absence of microhaematuria (> 50 RBCs per high power field), normal findings on renal ultrasonography. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | 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 | up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transplantation free survival | 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 | up to 3 years | 
| Regression of acute kidney injury | Regression is defined as movement of AKI to a lower stage and decrease of serum creatinine | up to 1 month | 
| Recurrence of acute kidney injury | From sample collection day to elevation day of creatinine | up to 1 year | 
| Progression to chronic kidney disease | From sample collection day to progression to CKD | 1 year | 
| Response rate to terlipressin | If reduction of creatinine 0.3mg/dL from the baseline | 1 week |