Recruiting
Phase 2

Rapid Hydration

Sponsor:

Columbia University

Code:

NCT07783191

Conditions

Hypernatremia

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Intravenous Dextrose 5% solution

Study Details

Brief summary:

The goal of this study is to show the feasibility of rapid identification, consenting, randomization, treatment, and follow-up of patients with severe hypernatremia (Na ≥ 155 mEq/L). The investigators plan to randomize 80 patients with severe hypernatremia to rapid hydration (aiming for a correction rate of 18m Eq/L/24h) versus standard of care therapy.

The aim of this study is to show the feasibility of the proposed protocol and to collect preliminary safety and efficacy data to inform a subsequent multicenter RCT powered to assess the effect of rapid hydration of patients with severe hypernatremia on 30-day survival.

Conditions

Hypernatremia

Study ID

NCT07783191

Start date

Oct 22, 2026

Status verified date

Oct, 2026

Completion date

May, 2029

Anticipated

Primary completion date

Feb, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Rapid hydration

Hydration with D5W solution targeting a correction rate of 18 meq/L/day (0.75 meq/L/hr) using the Adrogué-Madias formula

active comparator: Standard of care

Standard of care correction of hypernatremia

Interventions

Intravenous Dextrose 5% solution

sterile solution of glucose and water

Primary outcome measure

  • Sodium correction rate [ Time Frame: From treatment to hypernatremia correction (Na < 145 mEq/L), up to 30 days ]

Central Contacts and Locations

Central contacts

Daniel Shepshelovich, MD

212-305-9379ds4321@cumc.columbia.edu

Locations

Columbia University Irving Medical Center / New-York Presbyterian

Recruiting

New York, New York, United States, 10032

More Information

Sponsor

Columbia University

Last update posted

Oct 27, 2026

Last verified

Oct, 2026

Keywords

  • Hypernatremia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-28. This information was provided to ClinicalTrials.gov by Columbia University on 2026-10-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.