HyponatremiaNCT02012660
Relationship Between Heat Wave and Hyponatremia
An observational study of Hyponatremia, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
The objective of this study is to explore the relationship between moderate to severe hyponatremia and heat. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hyponatremia
- What is being tested?
- Seasonality
- How many people
- 28,734 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2014to Apr 2015
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults admitted to the emergency departement of a primary and tertiary care teaching hospital
Who may be able to join
- all adults (> 16 y) with blood natremia measured
Who cannot join
- Patients without measure of natremia in the emergency department
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between Heat Wave and Moderate to Severe Hyponatremia in the Emergency Departement of Primary and Tertiary Care Teaching Hospital.
The objective of this study is to explore the relationship between moderate to severe hyponatremia and heat.
Read the detailed description
We will explore the relationship between heat wave and moderate and severe hyponatremia in a population of adult patients admitted in the emergency department of a primary and tertiary care teaching urban hospital. We will compare the prevalence of hyponatremia between summer and winter periods. We will describe the types of observed hyponatremia and describe the characteristics of the patients suffering of moderate to severe hyponatremia.
- Conditions
- Hyponatremia
- Being tested
- Seasonality
- Medical subject headings
- Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeasonalityOther
Also called Summer = June, July, August, Winter = December, January, February
The impact of high temperature during summer months on the prevalence of hyponatremia will be explores.
| Study group | Role | What they receive |
|---|---|---|
| Hyponatremia, seasonality | Summer months = June, July, August Winter months = December, January, February Receives: Other: Seasonality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with moderate to severe hyponatremia
Moderate to severe hyponatremia is defined as Sodium blood levels < 125 mmol/L
Measured: Natremia measured at admission in the ED
Secondary outcomes (2)
Mortality
Measured: December 2011 to August 2013
Hospital length of stay
Measured: December 2011 to August 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study startFeb 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyponatremiaStudies 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
- Time perspective
- Retrospective
- Enrolment
- 28,734 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivier T. Rutschmann, University Hospital, Geneva
- Investigators
- Olivier T Rutschmann, MD, MPH, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02012660
- Sponsor's protocol ID
- SU-051213
- Status last verified
- Apr 2015
- First submitted
- 5 Dec 2013
- Last updated
- 29 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Heat Wave and Moderate to Severe Hyponatremia in the Emergency Departement of Primary and Tertiary Care Teaching Hospital.
- ClinicalTrials.gov ID
- NCT02012660
- Acronym / sponsor ID
- SU-051213
- Conditions
- Hyponatremia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28,734 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 16 Dec 2013 (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.
The objective of this study is to explore the relationship between moderate to severe hyponatremia and heat.
Detailed description
We will explore the relationship between heat wave and moderate and severe hyponatremia in a population of adult patients admitted in the emergency department of a primary and tertiary care teaching urban hospital. We will compare the prevalence of hyponatremia between summer and winter periods. We will describe the types of observed hyponatremia and describe the characteristics of the patients suffering of moderate to severe hyponatremia.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyponatremia, seasonality | – | Other: SeasonalitySummer months = June, July, August Winter months = December, January, February |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults admitted to the emergency departement of a primary and tertiary care teaching hospital
Key inclusion criteria (1 listed)
- all adults (> 16 y) with blood natremia measured
Key exclusion criteria (1 listed)
- Patients without measure of natremia in the emergency department
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SeasonalityAlso: Summer = June, July, August, Winter = December, January, FebruaryThe impact of high temperature during summer months on the prevalence of hyponatremia will be explores. | Other | Hyponatremia, seasonality |
Primary outcome
Number of patients with moderate to severe hyponatremia
Time frame: Natremia measured at admission in the ED
Moderate to severe hyponatremia is defined as Sodium blood levels < 125 mmol/L
2 secondary outcomes
Mortality
Time frame: December 2011 to August 2013
Hospital length of stay
Time frame: December 2011 to August 2013
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 29 Apr 2015.
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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.
Olivier T Rutschmann, MD, MPH principal investigator
University Hospital, Geneva
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 Hyponatremia, run by University Hospital, Geneva at 1 site in Switzerland.
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 29 Apr 2015. 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 Switzerland. 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?
Number of patients with moderate to severe hyponatremia (time frame: Natremia measured at admission in the ED). 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 29 Apr 2015.