Korean Cohort Study of AKI & HRS in Cirrhosis

Soon Chun Hyang University

Status: Unknown

Conditions: Acute Kidney Injury; Liver Cirrhosis; Hepatorenal Syndrome

Study type: Observational

Funder types: Other

Identifiers

NCT03530761

P-KAKI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 245 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

245 participants in 2 patient groups

Acute kidney injury

Description:

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

Description:

1. Diagnosis of cirrhosis and ascites, 2. Diagnosis of AKI according to ICA-AKI criteria 3. No response after 2 consecutive days of diuretic withdrawal and plasma volume expansion with albumin 1 g per kg of body weight 4. Absence of shock 5. No current or recent use of nephrotoxic drugs (non-steroidal anti-inflammatory drugs, aminoglycosides, iodinated contrast media, etc.) 6. 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.