Rapid hydration for severe hypernatremia
Official title: Rapid Rehydration in the Treatment of Severe Hypernatremia
Run by Columbia University · NCT07783191 · Data updated 2026-11-12
This study tests whether giving fast IV fluids to adults with very high sodium can be done safely and more effectively than standard care.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 21 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | October 22, 2026 |
| Main results expected | February 2029 |
| Study ends | May 2029 |
| Registry record updated | October 27, 2026 |
| Trial ID | NCT07783191 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 21 years or older presenting in ED/medical wards/MICU with Na ≥ 155 mEq/L at consent.
✕Probably not a fit
Patients who do not meet inclusion criteria or have contraindications to rapid hydration may not benefit and could be at risk from rapid correction.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a phase 2 feasibility randomized trial enrolling up to 80 adults with severe hypernatremia (Na ≥ 155 mEq/L). Participants are randomized to rapid hydration using a personalized, weight-based IV dextrose 5% solution aiming for a correction rate of 18 mEq/L per day versus standard-of-care therapy. The goal is to collect preliminary safety and efficacy data to inform a larger multicenter trial powered to look at 30-day mortality. Treatment fidelity and safety are monitored twice daily, with real-time protocol adjustments as needed.
Why it matters
Potential benefit: If successful, rapid hydration could reduce mortality and improve recovery for patients with severe hypernatremia.
How similar studies have gone: Prior retrospective studies suggested faster correction might be associated with lower mortality, but this is among limited evidence and this trial aims to provide controlled data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 21 years or older * In the ED/medical wards/MICU * Na ≥ 155mEq/L at consent. Exclusion Criteria: * Weight \< 40 kg or \> 120 kg * Unresolved hypotension: Two or more measurements of SBP \< 90mmHg or MAP \< 65mmHg, or any use of inotropes at the time eligibility is being assessed * Fingerstick or serum glucose \> 500mg/dL at the time eligibility is being assessed * Diabetic ketoacidosis * Diabetes insipidus * Acute or chronic need for dialysis, or unresolved urinary obstruction * Recent (30 days) cerebrovascular accident, clinical seizures, evidence of CNS mass, herniation, midline shift or vasogenic edema, or any CNS invasive procedure * Recent (30 days) of acute coronary syndrome, congestive heart failure exacerbation, arrhythmia, or invasive cardiac procedure, not including diagnostic cardiac catheterization without intervention * Women who are pregnant or breastfeeding * Patients receiving only comfort care measures * Previously enrolled in this trial * Legally authorized representative unable to consent in English or Spanish
Where it's running
-
Columbia University Irving Medical Center / New-York Presbyterian
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Daniel Shepshelovich, MD — Columbia University
- Study coordinator: Daniel Shepshelovich, MD
- Email: ds4321@cumc.columbia.edu
- Phone: 212-305-9379
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.