Clinical trial NCT03263598: Validation of Diagnostic Usefulness of the Random Urine Na/K Ratio for Replacement of 24hr Urine Na Excretion in Cirrhotic Patients With Ascites
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Cirrhosis
Ascites
Keywords: liver cirrhosis
ascites
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
Collaborators: name: Yeungnam University College of Medicine
name: Kyungpook National University Hospital
name: Daegu Catholic University Medical Center
name: DongGuk University
First posted: 2017-08-28
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Volunteers from the patient population including liver cirrhosis with ascites in multi-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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: After 24 hours of urine collection
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Jang Byoung Kuk
state: Kyoungpuk
Study officials:
References: