Efficacy and Safety of Rapid Intermittent Correction Compared With Slow Continuous Correction in Patients With Severe Hypernatremia

• Status: Not yet recruiting
• Trial end date: 2026-05-31
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy and safety of rapid intermittent correction and slow correction with an electrolyte-free solution in patients with severe hypernatremia (glucose-corrected serum sodium, ≥ 155 mmol/L).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital

Criteria

Inclusion Criteria:

• Patients who visit the emergency department and in-patients over 18 years

• Severe hypernatremia: glucose-corrected serum sodium ≥ 155 mmol/L

• Written consent

Exclusion Criteria:

• Arterial hypotension requiring inotropes or vasopressors (systolic blood pressure < 90 mmHg and mean arterial pressure < 70 mmHg)

• Anuria or bilateral urinary outlet obstruction

• Uncontrolled diabetes mellitus (HbA1C > 9%) or glucose at baseline > 500 mg/dL or diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome

• Decompensated liver cirrhosis (LC) - Known LC with ascites or diuretic use or hepatic encephalopathy or varix

• End-stage renal disease receiving renal replacement therapy

• Women who are pregnant or breast feeding

• Patients with the following conditions within 30 days prior to randomization:

1. History of cardiac surgery excluding PCA, acute myocardial infarction, sustained ventricular tachycardia, ventricular fibrillation, acute coronary syndrome, and admission for heart failure

2. Uncontrolled increase of intracranial pressure

• The subjects judged by investigators to have difficulty continuing the trial were also excluded.