Comparing rapid and slow correction methods for severe hypernatremia

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

This study is testing whether quickly or slowly lowering high sodium levels in the blood is safer and more effective for people who are very sick or elderly.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 144 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Seoul National University Hospital (other)
• Locations: 1 site (Hwaseong, Gyeonggi-do)
• Trial ID: NCT04949139 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of two different methods for correcting severe hypernatremia: rapid intermittent correction versus slow continuous correction using an electrolyte-free solution. Hypernatremia, characterized by elevated serum sodium levels, can lead to serious complications, particularly in vulnerable populations such as the elderly and critically ill patients. The study aims to determine the optimal correction rate to minimize risks associated with both rapid and slow correction methods. Participants will be monitored for safety and efficacy outcomes during treatment.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 years with severe hypernatremia (glucose-corrected serum sodium ≥ 155 mmol/L) who present to the emergency department or are hospitalized.

Not a fit: Patients with conditions such as uncontrolled diabetes, end-stage renal disease, or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment protocols for severe hypernatremia, potentially reducing mortality and morbidity in affected patients.

How similar studies have performed: While some studies have explored rapid correction methods in pediatric patients, this approach in adults is relatively novel and has not been extensively tested.

Eligibility 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 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

Where this trial is running

Hwaseong, Gyeonggi-do

• Hallym University Dongtan Sacred Heart Hospital — Hwaseong, Gyeonggi-do, Korea, Republic of (RECRUITING)

Study contacts

• Study coordinator: Sejoong Kim, PhD

Conditions: Hypernatremia, Treatment, 5% dextrose water