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Korean Cohort Study of AKI & HRS in Cirrhosis

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03530761
Enrollment
245
Registered
2018-05-21
Start date
2017-08-01
Completion date
2019-12-31
Last updated
2018-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Hepatorenal Syndrome, Liver Cirrhosis

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.

Interventions

None listed

Sponsors

Soonchunhyang University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Overall survivalup to 3 yearsFrom 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

MeasureTime frameDescription
Transplantation free survivalup to 3 yearsFrom 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 injuryup to 1 monthRegression is defined as movement of AKI to a lower stage and decrease of serum creatinine
Recurrence of acute kidney injuryup to 1 yearFrom sample collection day to elevation day of creatinine
Progression to chronic kidney disease1 yearFrom sample collection day to progression to CKD
Response rate to terlipressin1 weekIf reduction of creatinine 0.3mg/dL from the baseline

Countries

South Korea

Contacts

Primary ContactJeong-Ju Yoo, Doctor
puby17@naver.com82-10-9676-3128

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026