Viewing Study NCT00324883



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Last Modification Date: 2024-10-26 @ 9:24 AM
Study NCT ID: NCT00324883
Status: COMPLETED
Last Update Posted: 2013-07-09
First Post: 2006-05-09

Brief Title: Urine ChlorideCreatinine Ratio for Estimation of Urine Sodium
Sponsor: Weill Medical College of Cornell University
Organization: Weill Medical College of Cornell University

Study Overview

Official Title: Urine ChlorideCreatinine Ratio for Estimation of Urine Sodium
Status: COMPLETED
Status Verified Date: 2013-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 chloridecreatinine 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 chloridecreatinine ratio as described

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None