HyponatremiaNCT01326429
Frequency and Origin of Dysnatremias in the Emergency Department
An observational study of Hyponatremia and Hypernatremia, run by Insel Gruppe AG, University Hospital Bern.
Trial summary
Hypo- and hypernatremia are the most frequent electrolyte disorders found in hospitalized patients. The increasing use of diuretics and other medications influencing the water and sodium homeostasis potentially lead to a rise in the prevalence of the electrolyte disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyponatremia, Hypernatremia
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Mar 2013
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All patients admitted to the emergency department of a large tertiary university hospital with a serum sodium below 135 mmol/L (hyponatremia) or exceeding 145 mmol/L.
Who may be able to join
- Serum sodium below 135 mmol/L (i.e. hyponatremia); serum sodium exceeding 145 mmol/L (hypernatremia)
Who cannot join
- Patients below age 18 years; patients declining study participation.
About this study
Hypo- and hypernatremia are the most frequent electrolyte disorders found in hospitalized patients. The increasing use of diuretics and other medications influencing the water and sodium homeostasis potentially lead to a rise in the prevalence of the electrolyte disorders. Only little data is available on the frequency and the mechanisms leading to hypo-/hypernatremia.
Thus, the investigators aim to A.) determine the frequency of hypo- and hypernatremia in the emergency department of a large tertiary university hospital and B.) explore the mechanisms leading to the development of dysnatremias by detailed clinical and laboratory examinations.
- Conditions
- Hyponatremia, Hypernatremia
- Keywords
- Sodium, Hyponatremia, Hypernatremia, Emergency department
- Medical subject headings
- Hyponatremia, Hypernatremia, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hypernatremia | Patients admitted to the emergency department with a serum sodium exceeding 145 mmol/L. | |
| Hyponatremia | Patients admitted to the emergency room with a serum sodium below 135 mmol/L. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of hypo- and hypernatremia in the emergency department
The investigators aim to determine the frequency of hypo- and hypernatremia in the emergency department of a large tertiary university hospital.
Measured: approx. 6 months
Secondary outcomes (1)
Origin of hypo- and hypernatremia in the emergency department
The investigators try to investigate the mechanisms leading to the development of hypo- and hypernatremia in patients admitted to the emergency department.
Measured: approx. 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2011 (estimated)
- Study startOct 2011
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: Job change of responsible investigators
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.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Steering committee of the NCCR
- Investigators
- Gregor Lindner, M.D., Principal investigator, Dept. of Nephrology and Hypertension, Inselspital Bern, University of BernFelix J Frey, M.D., Study chair, Dept. of Nephrology and Hypertension, Inselspital Bern, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01326429
- Sponsor's protocol ID
- KEK 019/11
- Status last verified
- Jul 2015
- First submitted
- 29 Mar 2011
- Last updated
- 23 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency and Origin of Dysnatremias in the Emergency Department
- ClinicalTrials.gov ID
- NCT01326429
- Acronym / sponsor ID
- KEK 019/11
- Conditions
- Hyponatremia, Hypernatremia
- Keywords
- Sodium, Hyponatremia, Hypernatremia, Emergency department
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Job change of responsible investigators
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Steering committee of the NCCR
- Study start
- Oct 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 30 Mar 2011 (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.
Hypo- and hypernatremia are the most frequent electrolyte disorders found in hospitalized patients. The increasing use of diuretics and other medications influencing the water and sodium homeostasis potentially lead to a rise in the prevalence of the electrolyte disorders. Only little data is available on the frequency and the mechanisms leading to hypo-/hypernatremia.
Thus, the investigators aim to A.) determine the frequency of hypo- and hypernatremia in the emergency department of a large tertiary university hospital and B.) explore the mechanisms leading to the development of dysnatremias by detailed clinical and laboratory examinations.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypernatremia | – | –Patients admitted to the emergency department with a serum sodium exceeding 145 mmol/L. |
| Hyponatremia | – | –Patients admitted to the emergency room with a serum sodium below 135 mmol/L. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to the emergency department of a large tertiary university hospital with a serum sodium below 135 mmol/L (hyponatremia) or exceeding 145 mmol/L.
Key inclusion criteria (1 listed)
- Serum sodium below 135 mmol/L (i.e. hyponatremia); serum sodium exceeding 145 mmol/L (hypernatremia)
Key exclusion criteria (1 listed)
- Patients below age 18 years; patients declining study participation.
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
Frequency of hypo- and hypernatremia in the emergency department
Time frame: approx. 6 months
The investigators aim to determine the frequency of hypo- and hypernatremia in the emergency department of a large tertiary university hospital.
1 secondary outcome
Origin of hypo- and hypernatremia in the emergency department
Time frame: approx. 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2015.
- Institution homepageLink provided by the sponsor.
Related trials for Hyponatremia
RecruitingPhase 3
Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia
Hyponatremia
Enrolling by invitationObservational study
International Multi-center Retrospective Study of Patients With Serum Sodium ≤110 mmol/L to Determine the Relationship Between Osmotic Demyelination Syndrome (ODS) and Rapid Correction of Hyponatremia
Hyponatremia Symptomatic, Osmotic Demyelination Syndrome
Active, not recruitingObservational study
Samsca Post-marketing General Drug Use-results Survey in Patients With Hyponatremia in SIADH
Antidiuretic Hormone, Inappropriate Secretion
Recruiting
Urea for Treatment of Hyponatremia in Patients With SIAD Unresponsive to Fluid Restriction
SIAD - Syndrome of Inappropriate Antidiuresis
Active, not recruitingObservational study
Hyponatremia - Complications, Prognosis, Epidemiology in Finnish Tertiary Care
Hyponatremia, Osmotic Demyelination Syndrome
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.
Gregor Lindner, M.D. principal investigator
Dept. of Nephrology and Hypertension, Inselspital Bern, University of Bern
Felix J Frey, M.D. study chair
Dept. of Nephrology and Hypertension, Inselspital Bern, University of Bern
Questions about this trial
What is this clinical trial studying?
An observational study of Hyponatremia and Hypernatremia, run by Insel Gruppe AG, University Hospital Bern.
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: withdrawn, as of the sponsor's last update on 23 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Frequency of hypo- and hypernatremia in the emergency department (time frame: approx. 6 months). 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 23 Jul 2015.