HypertensionNCT00324883
Urine Chloride/Creatinine Ratio for Estimation of Urine Sodium
An observational study of Hypertension, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Over 21 years of age.
Who cannot join
- No exclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College of Cornell University
New York, New York, 10021
About this study
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.
Read the 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.
- Conditions
- Hypertension
- Keywords
- sodium intake, sodium excretion, chloride excretion, creatinine, hypertension
- Medical subject headings
- Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
urine sodium excretion
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2006 (estimated)
- Study startMar 2006
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Allied Minds
- Responsible party
- Sponsor
- Investigators
- Samuel J Mann, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00324883
- Sponsor's protocol ID
- 0601008328
- Status last verified
- Jul 2013
- First submitted
- 9 May 2006
- Last updated
- 9 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urine Chloride/Creatinine Ratio for Estimation of Urine Sodium
- ClinicalTrials.gov ID
- NCT00324883
- Acronym / sponsor ID
- 0601008328
- Conditions
- Hypertension
- Keywords
- sodium intake, sodium excretion, chloride excretion, creatinine, hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Allied Minds
- Study start
- Mar 2006
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 11 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Over 21 years of age.
Key exclusion criteria (1 listed)
- No exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
urine sodium excretion
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel J Mann, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
urine sodium excretion (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2013; AzTrials last refreshed its copy on 8 Nov 2026.