Korean Cohort Study of AKI & HRS in Cirrhosis

May 8, 2018 updated by: Sang Gyune Kim, Soonchunhyang University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

245

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Korea, Republic of
- Gyeonggi Do
  - Bucheon, Gyeonggi Do, Korea, Republic of, 14584
    - Recruiting
    - Soonchunhyang University Bucheon Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with liver cirrhosis diagnosed as acute kidney injury or hepatorenal syndrome

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Acute kidney injury 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 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.

Group / Cohort

Acute kidney injury

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

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?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival Time Frame: 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	up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transplantation free survival Time Frame: 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	up to 3 years
Regression of acute kidney injury Time Frame: up to 1 month	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 Time Frame: up to 1 year	From sample collection day to elevation day of creatinine	up to 1 year
Progression to chronic kidney disease Time Frame: 1 year	From sample collection day to progression to CKD	1 year
Response rate to terlipressin Time Frame: 1 week	If reduction of creatinine 0.3mg/dL from the baseline	1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soonchunhyang University Hospital

Investigators

Principal Investigator: Jeong-Ju Yoo, Doctor, Soonchunhyang University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2017

Primary Completion (ANTICIPATED)

December 31, 2018

Study Completion (ANTICIPATED)

December 31, 2019

Study Registration Dates

First Submitted

April 25, 2018

First Submitted That Met QC Criteria

May 8, 2018

First Posted (ACTUAL)

May 21, 2018

Study Record Updates

Last Update Posted (ACTUAL)