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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03263598
Other study ID # random Urine Na/K
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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