Efficacy and Safety of Rapid Intermittent Correction Compared With Slow Continuous Correction in Patients With Severe Hypernatremia (SALSAII)
Hypernatremia
About this trial
This is an interventional treatment trial for Hypernatremia focused on measuring Hypernatremia, Treatment, 5% dextrose water
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:
- History of cardiac surgery excluding PCA, acute myocardial infarction, sustained ventricular tachycardia, ventricular fibrillation, acute coronary syndrome, and admission for heart failure
- 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
Sites / Locations
- Hallym University Dongtan Sacred Heart HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Rapid intermittent bolus group
Slow continuous infusion group
A : males < 65 ; B : females < 65 or males ≥ 65 ; C : females ≥ 65 yrs <During the first 3 h> Primary treatment over 1h A: 5DW 8 B: 5DW 7 C: 5DW 6 mL/kg If undercorrected, Repeat the 5DW amount infused during primary treatment after 3 h <At 3-24 h> Modify protocol based on sNa at each time point (6/12/18/24 h) Check U/S ratio at 0 h undercorrection < 0.5: repeat the amount infused during primary treatment q 3 h ≥ 0.5: repeat the amount infused during primary treatment q 6 h target correction < 0.5: repeat the amount infused during primary treatment q 6 h ≥ 0.5: stop the infusion <At 24-48 h> Modify protocol based on sNa at each time point (30/36/42/48 h) Check U/S ratio at 24 h undercorrection < 0.5: repeat the amount infused during primary treatment q 3 h ≥ 0.5: repeat the amount infused during primary treatment q 6 h target correction < 0.5: repeat the amount infused during primary treatment q 6 h ≥ 0.5: stop the infusion
Participants will be divided into three groups same as above <During the first 3 h> Primary treatment A: 5DW 1.8 B: 5DW 1.57 C: 5DW 1.35 mL/kg/h Modify protocol as described below based on sNa measurement at 3 h undercorrection: maintain the infusion rate target correction: stop the infusion <At 3-24 h> Modify protocol based on sNa measurement at each time point (6/12/18/24 h) Check U/S ratio at 0 h • undercorrection < 0.5: increase the infusion rate to twice that of the primary treatment ≥ 0.5: maintain the infusion rate • target correction < 0.5: maintain the infusion rate ≥ 0.5: stop the infusion <At 24-48 h> Modify protocol based on sNa measurement at each time point (30/36/42/48 h) Check U/S ratio at 24 h • undercorrection < 0.5: increase the infusion rate to twice that of the primary treatment ≥ 0.5: maintain the infusion rate • target correction < 0.5: maintain the infusion rate ≥ 0.5: stop the infusion