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Completed

NCT Number: NCT03263598

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

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).

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Key information

Conditions

Liver Cirrhosis Ascites Digestive System Diseases Fibrosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jang Byoung Kuk

Daegu, Kyoungpuk, 410-773, South Korea

About this study

● Detailed Description:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Jang Byoung Kuk

Other

Collaborators

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

Registry information

Official study title

Clinical Significance and Correlation Between the 24-Hour Urine Sodium Excretion and the Spot Urine Na/K Ratio in Cirrhotic Patients With Ascites.

Acronym: urine Na/K

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Aug 28, 2017
Registry last updated
Feb 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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