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

NCT03263598 | Completed

• 1 other identifier: random Urine Na/K
• Study Type: observational
• Target: 195
• Locations: 1 country
• Sites: 1

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).

Conditions

Liver Cirrhosis; Ascites

Keywords

liver cirrhosis; ascites

Outcome Measures

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.

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Volunteers from the patient population including liver cirrhosis with ascites in multi-center.

You may qualify if:

• Liver cirrhotic patients with ascites diagnosed by imaging study, biopsy or clinically, regardless of taking diuretics.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jang Byoung Kuk: lead
• Yeungnam University College of Medicine: collaborator
• Kyungpook National University Hospital: collaborator
• Daegu Catholic University Medical Center: collaborator
• DongGuk University: collaborator

Study Sites (1)

Jang Byoung Kuk

Daegu, Kyoungpuk, 410-773, South Korea

Location

MeSH Terms

Conditions

Liver Cirrhosis; Ascites

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Keimyung University Dongsan medical center

Study Record Dates

• First Submitted: August 18, 2016
• First Posted: August 28, 2017
• Study Start: May 1, 2016
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: February 21, 2020

Record last verified: 2020-02

Locations

KR (1)