Clinical trial NCT00324883: Urine Chloride/Creatinine Ratio for Estimation of Urine Sodium
Official title: Urine Chloride/Creatinine Ratio for Estimation of Urine Sodium
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: sodium intake
sodium excretion
chloride excretion
creatinine
hypertension
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Allied Minds
First posted: 2006-05-11
Enrollment: 81
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: volunteers from patient population including hypertensive and normotensive individuals, and hypertensive and normotensive volunteers recruited by advertising. Age \>21 excluding individuals with unstable changes in renal function.

Brief summary: We plan to assess the accuracy of a new means of estimating urine sodium excretion. We will compare the chloride to creatinine ratio obtained by titrator sticks with urine sodium measured by a standard laboratory. If found to approximate sodium excretion, the titrator sticks could provide a convenient means for doctors and patients to monitor their salt intake.

Detailed description: Level of salt intake has an important impact in patients with high blood pressure or congestive heart failure. Despite this there is no convenient way for doctors or patients to assess their salt intake other than diet recall, which is unreliable, or measurement of sodium excretion in a 24 hour collection of urine, which is very inconvenient. As a result, salt intake is not monitored in most patients.

2 innovations might enable a more convenient assessment of salt intake. A titrator stick that measures chloride ion concentration (chloride and sodium concentrations correlate strongly with each other), and a titrator stick that measures urine creatinine. The latter enables estimation of 24 hour excretion from a single sample of urine. In assessing sodium intake, a measurement that provides an approximation of urine sodium intake would be of considerable clinical value

In this study, we shall compare the estimation of urine sodium excretion measured by a laboratory with estimation of sodium excretion from measurement of chloride/creatinine ration in a random urine sample. We will compare the estimate obtained by titrator stick with the sodium concentration from the same urine sample, and from measurements obtained from a 24 hour urine collection. In the next phase we will also compare the average estimate from titrator stick obtained on 3 different days with the measurement obtained from 3 24 hour urine collections.

We will assess the accuracy with which the titrator stick estimate approximates the measured urine sodium.

As of March 2007, we have recruited 50 subjects, and continue to study the predictive value of spot urine chloride/creatinine ratio, as described.

Eligibility criteria: Inclusion Criteria:

Over 21 years of age.

Exclusion Criteria:

No exclusion criteria.

Primary outcomes:
measure: urine sodium excretion
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College of Cornell University
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Samuel J Mann, MD
role: PRINCIPAL_INVESTIGATOR
References: