Urine Chloride/Creatinine Ratio for Estimation of Urine Sodium

This study has been completed.
Sponsor:
Collaborator:
Allied Minds
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00324883
First received: May 9, 2006
Last updated: July 8, 2013
Last verified: July 2013
  Purpose

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
Hypertension

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Urine Chloride/Creatinine Ratio for Estimation of Urine Sodium

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • urine sodium excretion [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

urine


Enrollment: 81
Study Start Date: March 2006
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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.

Criteria

Inclusion Criteria:

Over 21 years of age.

Exclusion Criteria:

No exclusion criteria.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00324883

Locations
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
Investigators
Principal Investigator: Samuel J Mann, MD Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00324883     History of Changes
Other Study ID Numbers: 0601008328
Study First Received: May 9, 2006
Last Updated: July 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Weill Medical College of Cornell University:
sodium intake
sodium excretion
chloride excretion
creatinine
hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 29, 2014