HypernatremiaNATSAUNCT04265976
ED Hypernatremia. Prognostic Factors and Epidemiology.
An observational study of Hypernatremia, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
This study evaluate the 1-month mortality of patients who proceed a blood sample while in the ED with an hypernatremia (>145 mmol/l). This prospective study will try to show several prognostic factors, and show the epidemiology of hypernatremia in this single center evaluation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypernatremia
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 26 Aug 2019to 1 Sep 2020
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Every >18 years old patient from who a blood sample was taken in the ED with a natremia > 145 mmol/l and don't show a refusal after information.
Who may be able to join
- Natremia > 145 mmol/l
Who cannot join
- Age < 18 years
- Refusal
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Besançon
Besançon, 25000
Romain ADAM, Resident, +33646470168, radam@chu-besancon.fr
Noémie NMINEJ, nnminej@chu-besancon.fr
About this study
Official title: Emergency Departement (ED) Hypernatremia. Prognostic Factors and Epidemiology. About a Single-center Prospective Study
This study evaluate the 1-month mortality of patients who proceed a blood sample while in the ED with an hypernatremia (>145 mmol/l). This prospective study will try to show several prognostic factors, and show the epidemiology of hypernatremia in this single center evaluation.
- Conditions
- Hypernatremia
- Medical subject headings
- Hypernatremia
What is being measured
The primary outcome is the main question the study is designed to answer.
one month survival
Survival at 1 month after the blood sample at the ED
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start26 Aug 2019
- Primary completion26 May 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypernatremiaStudies of the same condition, open and under way.
- 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265976
- Sponsor's protocol ID
- P/2019/448
- Acronym
- NATSAU
- Status last verified
- Feb 2020
- First submitted
- 10 Feb 2020
- Last updated
- 17 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Departement (ED) Hypernatremia. Prognostic Factors and Epidemiology. About a Single-center Prospective Study
- ClinicalTrials.gov ID
- NCT04265976
- Acronym / sponsor ID
- NATSAU / P/2019/448
- Conditions
- Hypernatremia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- 26 May 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 12 Feb 2020 (actual)
- 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.
This study evaluate the 1-month mortality of patients who proceed a blood sample while in the ED with an hypernatremia (>145 mmol/l). This prospective study will try to show several prognostic factors, and show the epidemiology of hypernatremia in this single center evaluation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Every >18 years old patient from who a blood sample was taken in the ED with a natremia > 145 mmol/l and don't show a refusal after information.
Key inclusion criteria (1 listed)
- Natremia > 145 mmol/l
Key exclusion criteria (2 listed)
- Age < 18 years
- Refusal
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
one month survival
Time frame: 1 month
Survival at 1 month after the blood sample at the ED
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
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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.
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 Hypernatremia, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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 2 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: status not confirmed, as of the sponsor's last update on 17 Feb 2020. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Romain ADAM, Resident (+33646470168, radam@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
one month survival (time frame: 1 month). 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 17 Feb 2020.