Can rapid IV fluids outpace standard care for a Life-Threatening salt imbalance?
NCT ID NCT07783191
First seen Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time
Summary
This trial tests whether giving fluids more quickly than usual can safely correct severe hypernatremia, a dangerous condition where sodium levels in the blood are too high. Researchers will compare rapid rehydration against standard care in 80 adults with sodium levels of 155 mEq/L or higher. The goal is to see if this approach is feasible and to gather early data on safety and effectiveness, which could inform a larger study on survival outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Intravenous Dextrose 5% solution (D5W), a sterile glucose and water solution used for rapid rehydration
- What this could lead to
- If rapid rehydration proves safe and effective, it could become a standard approach to treat severe hypernatremia, potentially reducing complications and improving survival.
- What could go wrong
- This is a small phase 2 feasibility trial, so results may not be definitive. Rapid sodium correction carries risks, including neurological complications, and the approach may not be safe for all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Columbia University Irving Medical Center / New-York Presbyterian
New York, New York, 10032, United States