Efficacy and Safety of Rapid Intermittent Correction Compared With Slow Continuous Correction in Patients With Severe Hypernatremia (SALSA II Trial)

B-2104-680-003

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).

2021-05-01

2026-05-31

2026-05-31

Recruiting

Early phase I

144

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 uncontrolled diabetic ketoacidosis or uncontrolled 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 * Uncontrolled Heart failure (regardless of LVEF) * 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. * The case the subjects does not consent to the study

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 144, 'type': 'ESTIMATED'}}

2023-08-09