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

Sponsor
Kangbuk Samsung Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05389280
Collaborator
(none)
80
Enrollment
1
Location
12.3
Anticipated Duration (Months)
6.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Impact of Acute Kidney Injury on Sarcopenia and Frailty in Patients With Liver Cirrhosis
    Actual Study Start Date :
    Mar 23, 2022
    Anticipated Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Mar 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with Acute kidney injury [up to 24 weeks]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Liver cirrhosis

    • aged over 20 years

    Exclusion Criteria:

    • serum creatinine >1.5 mg/dL

    • on dialysis

    • liver transplant

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kangbuk Samsung Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Kangbuk Samsung Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Won Sohn, Principal Investigator, Kangbuk Samsung Hospital
    ClinicalTrials.gov Identifier:
    NCT05389280
    Other Study ID Numbers:
    • KBSMCLC2022
    First Posted:
    May 25, 2022
    Last Update Posted:
    May 25, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Liver Cirrhosis
    Sarcopenia
    Acute Kidney Injury
    Fibrosis
    Frailty
    Wounds and Injuries

    Study Results

    No Results Posted as of May 25, 2022