HyponatremiaProfHN_in_ZNANCT06781710
Analysis of the Epidemiology, Clinical Presentation and Therapy as Well as Therapy-associated Risk of Demyelination Syndrome in Patients With Profound Hyponatremia in the Emergency Department
An observational study of Hyponatremia, run by University of Cologne at 1 site in Germany.
Trial summary
Hyponatremia is a frequent cause for presentation to the emergency department (ED). While patients with chronic hyponatremia often exhibit minor symptoms, acute development of hyponatremia can lead to global cerebral edema, transtentorial herniation and death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyponatremia
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2024to 31 Dec 2025
- 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: Patients with profound hyponatremia presenting to the emergency department
Who may be able to join
- Adult patients ≥18 years
- Plasma sodium ≤125 mmol/L in the initial blood sample after admission to the Emergency Department
Who cannot join
- Lack of follow-up sodium analyses within the first 24 hours after admission
- initial blood glucose >300 mg/dL
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Analysis of the Epidemiology, Clinical Presentation and Therapy as Well as Therapy-associated Risk of Demyelination Syndrome in Patients With Profound Hyponatremia in the Emergency Department
Hyponatremia is a frequent cause for presentation to the emergency department (ED). While patients with chronic hyponatremia often exhibit minor symptoms, acute development of hyponatremia can lead to global cerebral edema, transtentorial herniation and death. The time course of hyponatremia development is usually not known to the treating physician at presentation. Hence, type and extent of therapy depend on the presence or absence of severe symptoms such as coma, seizures, obtundation or vomiting. It is believed that these are suggestive of increased cerebral pressure and indicative of cerebral edema. International guidance thus demands aggressive therapy with hypertonic saline at their occurrence. However, severe symptoms can also be found in patients with chronic hyponatremia (i.e., development in more than 48 hours) which are not at risk for developing cerebral edema due to adaptive counter measures in the brain. Although the percentage of patients with severe symptoms in chronic hyponatremia is considerably smaller than in acute hyponatremia, a higher incidence of chronic hyponatremia may lead to a larger overall number of severely symptomatic patients with chronic hyponatremia. The precise distribution of acute and chronic cases in the ED has not been established yet. In consequence, many patients with hyponatremia presenting with severe symptoms receive aggressive treatment in order to raise sodium levels, exposing them to the risk for overly rapid correction and osmotic demyelination syndrome (ODS). Current U.S. recommendations limit the sodium increase to a maximum of 8 mmol/L and 10-12 mmol/L in the first 24 hours in patients with high or low-to-moderate ODS risk, respectively. Similarly, the 2014 European Clinical Practice Guideline (ECPG) recommends a limit of 10 mmol/L in each 24h-period. These limits are often not accomplished in the real-world setting. In summary, weighing the risk of hyponatremia against complications associated with its (over-)correction constitutes a dilemma for the clinician. It will be strived to refine guidance on management of hyponatremia in patients with profound hyponatremia. Therefore, a better understanding of the proportions and characteristics of patients at risk for both cerebral edema and ODS is needed. The primary objective of this study is to determine the rate of hyponatremic patients who had already developed cerebral edema on admission and to identify patients who developed ODS during the index hospital stay. A secondary objective is a more detailed characterization of these subsets.
- Conditions
- Hyponatremia
- Keywords
- Hyponatremia, ODS, demyelination, overcorrection
- Medical subject headings
- Hyponatremia, Demyelinating Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients with cerebral edema
The primary aim is to determine the patient´s risk to develop cerebral edema, associated with hyponatremia and osmotic demyelination as a result of therapy, respectively.
Determination at admission as evidenced by imaging studies in the time period index admission in the Emergency Department until referral from the Emergency Department
Measured: on admission and within 2 hours after admission
rate of patients who develop osmotic demyelination syndrome (ODS)
The primary aim is to determine the patient´s risk to develop cerebral edema, associated with hyponatremia and osmotic demyelination as a result of therapy, respectively.
Determination as evidenced by imaging studies in the time period index admission until 90 days thereafter.
Measured: on admission and 90 days after admission
Secondary outcomes (4)
Risk factors associated with hyponatremia
Are there specific risk factors apart from hyponatremia or its management that influence the development of cerebral edema, respectively?
Measured: on admission
Risk factors associated with osmotic demyelination syndrome
Are there specific risk factors apart from hyponatremia or its management that influence the development of osmotic demyelination syndrome, respectively?
Measured: on admission
Proportion of patients with severe symptoms and characterization of severe symptoms of hyponatremia
Determine the rate of patients with profound hyponatremia that exhibit severe symptoms such as vomiting, obtundation, seizures, coma and cardiorespiratory distress.
Measured: on admission
Proportion of patients, in which ODS was considered "confirmed", "highly likely" and "possible", considering clinical and/or radiological features of ODS
Determine the rate of patients, in which ODS was considered "confirmed" in patients with classical radiological findings, "highly likely" in patients with clinical features of and radiological findings consistent with ODS, and "possible" in patients with clinical but no radiological features (or that had not received imaging)
Measured: at study end, 1 year after study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start1 Nov 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volker Burst, University of Cologne
- Investigators
- Volker Burst, MD, Principal investigator, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06781710
- Sponsor's protocol ID
- V1.0_23.09.2022
- Other IDs
- 22-1373-retro
- Acronym
- ProfHN_in_ZNA
- Status last verified
- Apr 2026
- First submitted
- 17 Dec 2024
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data base will be shared upon request
Publications
Burst V, Rabii R, Peto-Madew J, Persigehl T, Haneder S, Hackl MJ, Huser C, Trappe M, Cukoski S, Mollenhoff K, Suarez V. Severe Hyponatremia in the Emergency Department Incidence of Cerebral Edema and Risk of Osmotic Demyelination Syndrome. Acad Emerg Med. 2026 Jan;33(1):e70158. doi: 10.1111/acem.70158. Epub 2025 Oct 9.
PubMed 41069084
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of the Epidemiology, Clinical Presentation and Therapy as Well as Therapy-associated Risk of Demyelination Syndrome in Patients With Profound Hyponatremia in the Emergency Department
- ClinicalTrials.gov ID
- NCT06781710
- Acronym / sponsor ID
- ProfHN_in_ZNA / V1.0_23.09.2022
- Conditions
- Hyponatremia
- Keywords
- Hyponatremia, ODS, demyelination, overcorrection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 17 Jan 2025 (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.
Hyponatremia is a frequent cause for presentation to the emergency department (ED). While patients with chronic hyponatremia often exhibit minor symptoms, acute development of hyponatremia can lead to global cerebral edema, transtentorial herniation and death. The time course of hyponatremia development is usually not known to the treating physician at presentation. Hence, type and extent of therapy depend on the presence or absence of severe symptoms such as coma, seizures, obtundation or vomiting. It is believed that these are suggestive of increased cerebral pressure and indicative of cerebral edema. International guidance thus demands aggressive therapy with hypertonic saline at their occurrence. However, severe symptoms can also be found in patients with chronic hyponatremia (i.e., development in more than 48 hours) which are not at risk for developing cerebral edema due to adaptive counter measures in the brain. Although the percentage of patients with severe symptoms in chronic hyponatremia is considerably smaller than in acute hyponatremia, a higher incidence of chronic hyponatremia may lead to a larger overall number of severely symptomatic patients with chronic hyponatremia. The precise distribution of acute and chronic cases in the ED has not been established yet. In consequence, many patients with hyponatremia presenting with severe symptoms receive aggressive treatment in order to raise sodium levels, exposing them to the risk for overly rapid correction and osmotic demyelination syndrome (ODS). Current U.S. recommendations limit the sodium increase to a maximum of 8 mmol/L and 10-12 mmol/L in the first 24 hours in patients with high or low-to-moderate ODS risk, respectively. Similarly, the 2014 European Clinical Practice Guideline (ECPG) recommends a limit of 10 mmol/L in each 24h-period. These limits are often not accomplished in the real-world setting. In summary, weighing the risk of hyponatremia against complications associated with its (over-)correction constitutes a dilemma for the clinician. It will be strived to refine guidance on management of hyponatremia in patients with profound hyponatremia. Therefore, a better understanding of the proportions and characteristics of patients at risk for both cerebral edema and ODS is needed. The primary objective of this study is to determine the rate of hyponatremic patients who had already developed cerebral edema on admission and to identify patients who developed ODS during the index hospital stay. A secondary objective is a more detailed characterization of these subsets.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with profound hyponatremia presenting to the emergency department
Key inclusion criteria (2 listed)
- Adult patients ≥18 years
- Plasma sodium ≤125 mmol/L in the initial blood sample after admission to the Emergency Department
Key exclusion criteria (2 listed)
- Lack of follow-up sodium analyses within the first 24 hours after admission
- initial blood glucose >300 mg/dL
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
Rate of patients with cerebral edema
Time frame: on admission and within 2 hours after admission
The primary aim is to determine the patient´s risk to develop cerebral edema, associated with hyponatremia and osmotic demyelination as a result of therapy, respectively. Determination at admission as evidenced by imaging studies in the time period index admission in the Emergency Department until referral from the Emergency Department
rate of patients who develop osmotic demyelination syndrome (ODS)
Time frame: on admission and 90 days after admission
The primary aim is to determine the patient´s risk to develop cerebral edema, associated with hyponatremia and osmotic demyelination as a result of therapy, respectively. Determination as evidenced by imaging studies in the time period index admission until 90 days thereafter.
4 secondary outcomes
Risk factors associated with hyponatremia
Time frame: on admission
Risk factors associated with osmotic demyelination syndrome
Time frame: on admission
Proportion of patients with severe symptoms and characterization of severe symptoms of hyponatremia
Time frame: on admission
Proportion of patients, in which ODS was considered "confirmed", "highly likely" and "possible", considering clinical and/or radiological features of ODS
Time frame: at study end, 1 year after study start
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 30 Apr 2026.
- Derived from this study: PubMed 41069084Burst V, Rabii R, Peto-Madew J, Persigehl T, Haneder S, Hackl MJ, Huser C, Trappe M, Cukoski S, Mollenhoff K, Suarez V. Severe Hyponatremia in the Emergency Department Incidence of Cerebral Edema and Risk of Osmotic Demyelination Syndrome. Acad Emerg Med. 2026 Jan;33(1):e70158. doi: 10.1111/acem.70158. Epub 2025 Oct 9.
- Individual participant dataSharing planned: No. Data base will be shared upon request
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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.
Volker Burst, MD principal investigator
University Hospital of Cologne
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 of Cologne at 1 site in Germany.
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 2 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: finished, as of the sponsor's last update on 30 Apr 2026. 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 Germany. 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?
Rate of patients with cerebral edema (time frame: on admission and within 2 hours after admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06781710, which also lists 1 linked publication.
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 30 Apr 2026.