Rapid Rehydration for Hypernatremia
(RaRe Treat Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Daniel Shepshelovich, MD
Principal Investigator
Columbia University
Are You a Good Fit for This Trial?
This trial is for adults (21+) in the hospital with very high blood sodium levels (Na ≥ 155 mEq/L). People can't join if they're underweight or overweight, have certain heart, brain, or kidney problems, are pregnant/breastfeeding, have extremely high blood sugar, need only comfort care, or can't consent in English/Spanish.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive rapid hydration or standard-of-care therapy for hypernatremia correction
Follow-up
Participants are monitored for safety and effectiveness after treatment, including 30-day survival ascertainment
What Are the Treatments Tested in This Trial?
Interventions
- Intravenous Dextrose 5% solution
Trial Overview
The study compares two ways to treat severe hypernatremia: rapid IV rehydration using Dextrose 5% solution versus standard treatment. Patients are randomly assigned to one of these groups to see which method works better and is safer.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Hydration with D5W solution targeting a correction rate of 18 meq/L/day (0.75 meq/L/hr) using the Adrogué-Madias formula
Standard of care correction of hypernatremia
Find a Clinic Near You
Who Is Running the Clinical Trial?
Columbia University
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
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