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NCT05389280 Clinical Trial

Impact of Acute Kidney Injury on Sarcopenia and Frailty in Patients With Liver Cirrhosis

Sarcopenia Clinical Trial

Official title:
Impact of Acute Kidney Injury on Sarcopenia and Frailty in Patients With Liver Cirrhosis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05389280
Other study ID # KBSMCLC2022
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 23, 2022
Est. completion date March 31, 2023

Study information
Verified date May 2022
Source Kangbuk Samsung Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The aim of this prospective observational study is to evaluate the impact of acute kidney injury on sarcopenia and frailty in patients with liver cirrhosis.

Description:

The aim of this prospective study is to collect data on patients with liver cirrhosis and to investigate the impact of acute kidney injury on sarcopenia and frailty in patients with liver cirrhosis. If patients agree to participate in this clinical trial, the patients' data (such as age, sex, height, weight, nutrition status [RFH-NPT], history of medication, laboratory findings, endoscopic findings, and radiologic findings) will be collected in a research database. Renal injury was measured using conventional and novel serum biomarkers (serum creatinine, cystatin-C, neutrophil gelatinase-associated lipocalin, kidney injury molecule 1, and interleukin-18. Sarcopenia was evaluated using skeletal muscle index on abdominal computed tomography. Frailty was measured using Liver Frailty Index. The research database will be updated to include data on patients' disease outcomes and follow-up care.

Recruitment information / eligibility
Status Recruiting
Enrollment 80
Est. completion date March 31, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: - Liver cirrhosis - aged over 20 years Exclusion Criteria: - serum creatinine >1.5 mg/dL - on dialysis - liver transplant

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Kangbuk Samsung Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Kangbuk Samsung Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants with Acute kidney injury an increase in SCr of 0.3 mg/dL (26.4 µmoL/L) in <48 hours, or a 50% increase in SCr from a baseline within =3 months up to 24 weeks
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