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urine Na/K: Validation of Diagnostic Usefulness of the Random Urine Na/K Ratio for Replacement of 24hr Urine Na Excretion in Cirrhotic Patients With Ascites

Sponsor
Jang Byoung Kuk (Other)
Overall Status
Completed
CT.gov ID
NCT03263598
Collaborator
Yeungnam University College of Medicine (Other), Kyungpook National University Hospital (Other), Daegu Catholic University Medical Center (Other), DongGuk University (Other)
195
Enrollment
1
Location
45
Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The low sodium intake is important for ascites control in liver cirrhosis patients. Therefore, World Health Organization (WHO) recommends reduction of sodium (Na) to 2g/day for adults. The 24-hour urine Na excretion has been regarded as a standard method to estimate the amount of daily dietary sodium intake. However, it is too inconvenient to apply to patients or the general population in practice. For this reason, it has been suggested that a spot urine Na/potassium (K) ratio could be replaced with the 24-hour urine Na excretion. However, the evidence is not sufficient for that. The investigators will evaluate the usefulness of spot urine Na/K ratio to estimate the dietary sodium intake. The investigators will also verify several formulas of estimating the 24-hour Na excretion with spot urine Na, K, Creatinine (Cr).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    ● Detailed Description:

    1. Measurements: they should be performed for 2 days (the urine collected within 24 hrs)

    • 24-hour urine Na, K and Creatinine (patients were instructed to collect all subsequent urine voids over the next 24-hour period including the first void of the following day.)

    • Spot urine Na, K, Creatinine with the same urine sample in some containers provided to patients. (every urination)

    1. Calculation

    • Na/K Ratio with spot urine Na, K

    • Estimating 24-hour urine Na with spot urine Na, K, Cr by using some formulas.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    195 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Clinical Significance and Correlation Between the 24-Hour Urine Sodium Excretion and the Spot Urine Na/K Ratio in Cirrhotic Patients With Ascites.
    Study Start Date :
    May 1, 2016
    Actual Primary Completion Date :
    Feb 1, 2020
    Actual Study Completion Date :
    Feb 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. To evaluate the usefulness of urine Na / K ratio as a clinical indicator to replace the 24-hour urine sodium excretion (mEq/L) in liver cirrhosis patients with ascites. [After 24 hours of urine collection]

      Previous studies have reported that the spot urine Na / K ratio is 90 percent accuracy compared to 24hr urine Na excretion. To verify this, measure spot urine Na, K (mEq/L) by using the same sample as the 24-hour sodium and creatinine excretion and confirm with receiver operator characteristic (ROC) curve to find the best cutoff point of spot urine Na / K ratio.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Liver cirrhotic patients with ascites diagnosed by imaging study, biopsy or clinically, regardless of taking diuretics.
    Exclusion Criteria:

    • Uncontrolled sepsis or systemic infection.

    • Serum Creatinine >1.5 mg/dL.

    • Patients who are being treated for cancers except hepatocellular carcinoma.

    • Patients who refuse the examine or are not cooperative.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jang Byoung Kuk Daegu Kyoungpuk Korea, Republic of 410-773

    Sponsors and Collaborators

    • Jang Byoung Kuk
    • Yeungnam University College of Medicine
    • Kyungpook National University Hospital
    • Daegu Catholic University Medical Center
    • DongGuk University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jang Byoung Kuk, Keimyung University Dongsan medical center, Keimyung University Dongsan Medical Center
    ClinicalTrials.gov Identifier:
    NCT03263598
    Other Study ID Numbers:
    • random Urine Na/K
    First Posted:
    Aug 28, 2017
    Last Update Posted:
    Feb 21, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Jang Byoung Kuk, Keimyung University Dongsan medical center, Keimyung University Dongsan Medical Center
    liver cirrhosis
    ascites
    Additional relevant MeSH terms:
    Liver Cirrhosis
    Fibrosis
    Ascites

    Study Results

    No Results Posted as of Feb 21, 2020