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

Completed

• Conditions: Liver Cirrhosis; Ascites

• Registration Number: NCT03263598
• Lead Sponsor: Jang Byoung Kuk

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).

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.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-08-18
• Study First Submitted QC: 2017-08-23
• Study First Posted: 2017-08-28
• Status Verified: 2020-02
• Primary Completion: 2020-02
• Study Completion: 2020-02
• Last Update Submitted: 2020-02-20
• Last Update Posted: 2020-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 195

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Jang Byoung Kuk; 🇰🇷 Daegu, Kyoungpuk, Korea, Republic of