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Urine Chloride/Creatinine Ratio for Estimation of Urine Sodium

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00324883
Recruitment Status : Completed
First Posted : May 11, 2006
Last Update Posted : July 9, 2013
Allied Minds
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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.

Condition or disease

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.

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Study Type : Observational
Actual Enrollment : 81 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Urine Chloride/Creatinine Ratio for Estimation of Urine Sodium
Study Start Date : March 2006
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. urine sodium excretion [ Time Frame: 24 hours ]

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Inclusion Criteria:

Over 21 years of age.

Exclusion Criteria:

No exclusion criteria.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00324883

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United States, New York
Weill Cornell Medical College of Cornell University
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Allied Minds
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Principal Investigator: Samuel J Mann, MD Weill Medical College of Cornell University
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Responsible Party: Weill Medical College of Cornell University Identifier: NCT00324883    
Other Study ID Numbers: 0601008328
First Posted: May 11, 2006    Key Record Dates
Last Update Posted: July 9, 2013
Last Verified: July 2013
Keywords provided by Weill Medical College of Cornell University:
sodium intake
sodium excretion
chloride excretion
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases