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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03263598
Recruitment Status : Completed
First Posted : August 28, 2017
Last Update Posted : February 21, 2020
Yeungnam University College of Medicine
Kyungpook National University Hospital
Daegu Catholic University Medical Center
DongGuk University
Information provided by (Responsible Party):
Jang Byoung Kuk, Keimyung University Dongsan Medical Center

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
Liver Cirrhosis Ascites

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)
  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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 195 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
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 2016
Actual Primary Completion Date : February 2020
Actual Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

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. [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Volunteers from the patient population including liver cirrhosis with ascites in multi-center.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03263598

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Korea, Republic of
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
Additional Information:

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Responsible Party: Jang Byoung Kuk, Keimyung University Dongsan medical center, Keimyung University Dongsan Medical Center Identifier: NCT03263598    
Other Study ID Numbers: random Urine Na/K
First Posted: August 28, 2017    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Jang Byoung Kuk, Keimyung University Dongsan Medical Center:
liver cirrhosis
Additional relevant MeSH terms:
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Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases