Liver Cirrhosis Clinical Trial
— urine Na/KOfficial title:
Clinical Significance and Correlation Between the 24-Hour Urine Sodium Excretion and the Spot Urine Na/K Ratio in Cirrhotic Patients With Ascites.
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 |
Verified date | February 2020 |
Source | Keimyung University Dongsan Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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).
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. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Jang Byoung Kuk | Daegu | Kyoungpuk |
Lead Sponsor | Collaborator |
---|---|
Jang Byoung Kuk | Daegu Catholic University Medical Center, DongGuk University, Kyungpook National University Hospital, Yeungnam University College of Medicine |
Korea, Republic of,
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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