Abstract: PO2636
Efficacy and Safety of Rapid Intermittent Correction vs. Slow Continuous Correction with Hypertonic Saline in Patients with Symptomatic Hyponatremia: A Randomized Clinical Trial (SALSA Trial)
Session Information
- Late-Breaking Clinical Trials Posters
October 22, 2020 | Location: On-Demand
Abstract Time: 10:00 AM - 10:00 AM
Category: Fluid, Electrolyte, and Acid-Base Disorders
- 902 Fluid, Electrolyte, and Acid-Base Disorders: Clinical
Authors
- Baek, Seon Ha, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, Gyeonggi, Korea (the Republic of)
- Kim, Sejoong, Seoul National University Bundang Hospital, Seongnam, Korea (the Republic of)
Background
Few high-quality evidences have clarified whether hypertonic saline is best administered as slow continuous infusion therapy (SCI) or rapid intermittent bolus therapy (RIB) for symptomatic severe hyponatremia.
Methods
Objective
To compare the efficacy and safety of RIB and SCI with hypertonic saline in patients with symptomatic severe hyponatremia.
Design
Prospective, investigator-initiated, multi center, open-label, randomized controlled study from 24 August 2016 until 21 August 2019
Setting
Emergency rooms and wards of three general hospitals in South Korea
Participants
178 patients aged >18 years with symptoms and glucose-corrected serum sodium (sNa) ≤125 mmol/L were included.
Interventions
Either RIB or SCI of 3% hypertonic saline for 24-48 hours stratified by the severity of clinical symptoms.
Main outcome and Measures
The primary outcome was overcorrection at any given period, defined as follows: increase in the sNa level by >12/18 mmol/L within 24/48 hours. Secondary outcomes included efficacy and safety of the treatment approaches. SNa concentrations were measured at every 6 hours for 2 days.
Results
Patients (mean age 73.1 years, 45% male, mean sNa concentrations 118.2 ± 5.0 mmol/L) were randomly assigned to RIB group (n=87) or SCI group (n=91). Overcorrection occurred in 17.2% and 24.2% in RIB and SCI groups, respectively (absolute risk difference, -6.9% [95% CI -18.8% to 4.9%]). RIB group showed lower incidence of re-lowering treatment than SCI group (41.4% vs 57.1%; absolute risk difference, -15.8% [95% CI -30.3% to -1.3%]; number needed to treat [NNT]=6.3). Groups did not differ in terms of efficacy in increasing sNa concentrations or improving symptoms but RIB showed better efficacy in achieving target correction rate within 1 hour (32.2% vs 17.6%, absolute risk difference 14.6% [95% CI 2% to 27.2%]; NNT=6.8).
Conclusion
Both RIB and SIC therapies of hypertonic saline for treating hyponatremic encephalopathy were effective and safe, with no difference in the overcorrection risk. However, RIB had a lower incidence of therapeutic re-lowering treatment and tended to have a better efficacy in achieving sNa within 1 hour than SCI. RIB could be suggested as the preferred treatment of symptomatic hyponatremia, consistent with the current consensus guidelines.
Funding
- Government Support - Non-U.S.