Rapid Rehydration for Severe Hypernatremia

Conditions

• Hypernatremia

Eligibility Criteria

Sex

ALL

Age

21 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Intravenous Dextrose 5% solution — DRUG
  sterile solution of glucose and water

Study Details

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.

Key Dates

First listed

Aug 24, 2026

Start date

Oct 31, 2026

Status verified

Aug 2026

Primary completion

Feb 28, 2029

Completion

May 31, 2029

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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

Primary Outcome Measure

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

Central Contacts

• Daniel Shepshelovich, MD
  212-305-9379
  [email protected]

Locations (1)

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