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

NCT ID: NCT03263598

Last Updated: 2020-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

195 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2020-02-29

Brief Summary

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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).

Detailed Description

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● 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)
2. Calculation

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

Conditions

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Liver Cirrhosis Ascites

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yeungnam University College of Medicine

OTHER

Sponsor Role collaborator

Kyungpook National University Hospital

OTHER

Sponsor Role collaborator

Daegu Catholic University Medical Center

OTHER

Sponsor Role collaborator

DongGuk University

OTHER

Sponsor Role collaborator

Jang Byoung Kuk

OTHER

Sponsor Role lead

Responsible Party

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Jang Byoung Kuk

Keimyung University Dongsan medical center

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Jang Byoung Kuk

Daegu, Kyoungpuk, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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random Urine Na/K

Identifier Type: -

Identifier Source: org_study_id

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