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

Liver Cirrhosis Clinical Trial

— urine Na/K  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03263598
• Other study ID #: random Urine Na/K
• Status: Completed
• Start date: May 2016
• Est. completion date: February 2020

Study information

• Verified date: February 2020
• Source: Keimyung University Dongsan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ascites
• Fibrosis
• Liver Cirrhosis

Locations

Country	Name	City	State
Korea, Republic of	Jang Byoung Kuk	Daegu	Kyoungpuk

Sponsors (5)

Lead Sponsor	Collaborator
Jang Byoung Kuk	Daegu Catholic University Medical Center, DongGuk University, Kyungpook National University Hospital, Yeungnam University College of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	After 24 hours of urine collection