Understanding the effects of severe low sodium levels in emergency patients
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
University of Cologne · NCT06781710
This study looks at patients with very low sodium levels who come to the emergency room to see how their symptoms and treatments affect their health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Cologne (other) |
| Locations | 1 site (Cologne) |
| Trial ID | NCT06781710 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients presenting to the emergency department with profound hyponatremia, defined as plasma sodium levels of 125 mmol/L or lower. It aims to analyze the epidemiology, clinical presentation, and treatment approaches for these patients, as well as the associated risks of demyelination syndrome due to therapy. The study will collect data on patient symptoms, treatment responses, and follow-up sodium levels to better understand the implications of acute versus chronic hyponatremia. By examining these factors, the research seeks to improve clinical decision-making in emergency settings.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with plasma sodium levels of 125 mmol/L or lower upon admission to the emergency department.
Not a fit: Patients who do not have follow-up sodium analyses within the first 24 hours after admission or have initial blood glucose levels above 300 mg/dL may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for patients with severe hyponatremia, potentially reducing the risk of serious complications.
How similar studies have performed: While there is ongoing research into hyponatremia management, this specific observational approach to understanding therapy-associated risks in emergency settings is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients ≥18 years * Plasma sodium ≤125 mmol/L in the initial blood sample after admission to the Emergency Department Exclusion Criteria: * Lack of follow-up sodium analyses within the first 24 hours after admission * initial blood glucose \>300 mg/dL
Where this trial is running
Cologne
- University Hospital of Cologne — Cologne, Germany (RECRUITING)
Study contacts
- Principal investigator: Volker Burst, MD — University Hospital Cologne
- Study coordinator: Volker Burst, MD
- Email: volker.burst@uk-koeln.de
- Phone: +49 221 47886285
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hyponatremia, ODS, demyelination, overcorrection