Evaluating electrolyte balance in hyponatremia treatment
Evaluation of Volume and Electrolyte Balance in Hyponatremia Treatment - a Prospective Observational Trial (EvenT)
This study is trying to see how different treatments for low sodium levels in the blood affect electrolyte balance and fluid changes in patients with hyponatremia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Cologne Academic / other |
| Locations | 1 site (Cologne) |
| Trial ID | NCT05692726 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the evolution of electrolyte-free water clearance and electrolyte mass balance in patients with non-hypervolemic hypotonic hyponatremia. It will gather prospective data to correlate initial sodium levels with plasma sodium evolution and electrolyte-free water changes. The study will also analyze anthropometric data and physiological responses to treatment, focusing on mechanisms of osmotic homeostasis and cell volume control. By understanding these patterns, the study seeks to improve treatment strategies for hyponatremia.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients aged 18 and older with hypotonic hyponatremia and specific plasma sodium and osmolality levels.
Not a fit: Patients with signs of extracellular volume expansion, liver cirrhosis, heart failure, or those on dialysis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients with hyponatremia, enhancing their treatment outcomes.
How similar studies have performed: While this study addresses a specific gap in understanding hyponatremia treatment, similar studies have shown varying degrees of success in managing electrolyte imbalances.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients ≥ 18 years * Hypotonic hyponatremia * glucose-corrected plasma sodium \<130 mmol/l * serum osmolality \<280 mosmol/kg or lack of signs of non-hypotonic hyponatremia Exclusion Criteria: * Signs of extracellular volume expansion * Patients with liver cirrhosis and severe liver damage AST/ALT\>3xULN, AP\>6xULN, Bilirubin ≥ 3mg/dl * Patients with heart failure * Patients on dialysis and/or patients with oliguric renal impairment and plasma creatinine ≥ 3mg/dl * Patients after organ transplantation
Where this trial is running
Cologne
- University Hospital of Cologne — Cologne, Germany (Recruiting)
Study contacts
- Principal investigator: Volker Burst, MD, Prof. — University Hospital of Cologne
- Study coordinator: Volker Burst, MD, Prof
- Email: volker.burst@uk-koeln.de
- Phone: +49 221-478-97222
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.