Columbia University
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.
Hypernatremia (high serum sodium) indicates a deficit in total body water. Hypernatremia is common in hospitalized patients and is associated with high mortality rates, directly associated with hypernatremia severity (30-70% for severe hypernatremia). The traditional approach is to correct hypernatremia slowly, not exceeding 0.5 mEq/L/hour or 10 mEq/L/day, using hypotonic intravenous fluids, to avoid hypothetical cerebral edema and related neurological complications. This treatment strategy is not supported by empirical clinical data in adults, and there are no convincing reports of neurologic…
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 m…
sterile solution of glucose and water
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