Rapid Rehydration for Severe Hypernatremia

NCT07783191 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: ACYY26621R01DK149765-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

Hypernatremia

Outcome Measures

Primary Outcomes (1)

• Sodium correction rate

  The sodium correction rate will be calculated by slope fitted using least squares estimate based on all sodium measurements (on 8-hour intervals) while on hydration regimen.

  From treatment to hypernatremia correction (Na < 145 mEq/L), up to 30 days

Secondary Outcomes (2)

• Hypernatremia correction within 24 hours

  24 hours from treatment

• Time to complete correction

  From treatment to hypernatremia correction (Na < 145 mEq/L), up to 30 days

Other Outcomes (5)

• Treatment fidelity

  From treatment until correction (Na < 145 mEq/L), up to 30 days

• Safety assessment completion

  From treatment until correction (Na < 145 mEq/L), up to 30 days

• 30-day survival ascertainment

  Day 30

Study Arms (2)

Rapid hydration

EXPERIMENTAL

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

Drug: Intravenous Dextrose 5% solution

Standard of care

ACTIVE COMPARATOR

Standard of care correction of hypernatremia

Drug: Intravenous Dextrose 5% solution

Interventions

Intravenous Dextrose 5% solution DRUG

sterile solution of glucose and water

Also known as: 5% Dextrose in Water, D5W

Rapid hydration; Standard of care

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 21 years or older
• In the ED/medical wards/MICU
• Na ≥ 155mEq/L at consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Columbia University Irving Medical Center / New-York Presbyterian

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Hypernatremia

Interventions

Solutions; Glucose; Water

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Hexoses; Monosaccharides; Sugars; Carbohydrates; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Daniel Shepshelovich, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Shepshelovich, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 24, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Scientific data will be shared as soon as possible. Scientific data included in published manuscripts will be available at the time of publication; all other generated scientific data will be shared no later than 1 month after completion of data analysis. The study data will be stored in the repository for at least 5 years.
• Access Criteria: All de-identified study data will be submitted to Zenodo, a generalist repository that is participating in the NIH Generalist Repository Ecosystem Initiative. To request access of the data, researchers will use the standard processes at Zenodo.

Locations

US (1)