SALSA
Trial question
What is the effect of rapid intermittent bolus infusion therapy of hypertonic saline in patients with symptomatic hyponatremia?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
55.0% female
45.0% male
N = 178
178 patients (98 female, 80 male).
Inclusion criteria: adults patients with moderately severe-to-severe hyponatremia and glucose-corrected serum sodium levels ≤ 125 mmol/L.
Key exclusion criteria: primary polydipsia; pregnancy or lactation; anuria; arterial hypotension; liver disease; uncontrolled diabetes mellitus; history of cardiac surgery; acute MI; sustained VT.
Interventions
N=87 rapid intermittent bolus (2-4 mL/kg 3% saline intravenous infusion over 20-40 minutes for 24-48 hours).
N=91 slow continuous infusion (0.5-1 mL/kg/hr 3% hypertonic saline for 24-48 hours).
Primary outcome
Incidence of overcorrection
17.2%
24.2%
24.2 %
18.1 %
12.1 %
6.0 %
0.0 %
Rapid intermittent
bolus
Slow continuous
infusion
No significant
difference ↔
No significant difference in incidence of overcorrection (17.2% vs. 24.2%; ARD -6.9, 95% CI -18.8 to 4.9).
Secondary outcomes
No significant difference in remaining symptoms at 24 hours (13.1% vs. 16.9%; ARD -3.8, 95% CI -14.4 to 6.8).
No significant difference in mean time to serum sodium elevation of ≥ 5 mmol/L (8.2 hours vs. 8.6 hours; AD -0.4 hours, 95% CI -2.7 to 2).
Significant decrease in incidence of relowering treatment (41.4% vs. 57.1%; ARD -15.8, 95% CI -30.3 to -1.3).
Safety outcomes
No significant differences in total amount of fluid and oral intake, use of furosemide for volume overload, and urine volume for 48 hours.
Significant differences in cumulative amount of hypertonic saline 3% administered within 1 (220.4 mL vs. 38.6 mL) and 6 hours (273.9 mL vs. 210.4 mL), respectively.
Conclusion
In adults patients with moderately severe-to-severe hyponatremia and glucose-corrected serum sodium levels ≤ 125 mmol/L, rapid intermittent bolus was not superior to slow continuous infusion with respect to incidence of overcorrection.
Reference
Seon Ha Baek, You Hwan Jo, Soyeon Ahn et al. Risk of Overcorrection in Rapid Intermittent Bolus vs Slow Continuous Infusion Therapies of Hypertonic Saline for Patients With Symptomatic Hyponatremia: The SALSA Randomized Clinical Trial. JAMA Intern Med. 2021 Jan 1;181(1):81-92.
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