Efficacy and safety of rapid intermittent correction compared with slow continuous correction with hypertonic saline in patients with moderately severe or severe symptomatic hyponatremia: study protocol for a randomized controlled trial (SALSA trial)

Anna Lee, You Hwan Jo, Kyuseok Kim, Soyeon Ahn, Yun Kyu Oh, Huijai Lee, Jonghwan Shin, Ho Jun Chin, Ki Young Na, Jung Bok Lee, Seon Ha Baek, Sejoong Kim, Anna Lee, You Hwan Jo, Kyuseok Kim, Soyeon Ahn, Yun Kyu Oh, Huijai Lee, Jonghwan Shin, Ho Jun Chin, Ki Young Na, Jung Bok Lee, Seon Ha Baek, Sejoong Kim

Abstract

Background: Hyponatremia is the most common electrolyte imbalance encountered in clinical practice, associated with increased mortality and length of hospital stay. However, no high-quality evidence regarding whether hypertonic saline is best administered as a continuous infusion or a bolus injection has been found to date. Therefore, in the current study, we will evaluate the efficacy and safety of rapid intermittent correction compared with slow continuous correction with hypertonic saline in patients with moderately severe or severe symptomatic hyponatremia.

Methods/design: This is a prospective, investigator-initiated, multicenter, open-label, randomized controlled study with two experimental therapy groups. A total of 178 patients with severe symptomatic hyponatremia will be enrolled and randomly assigned to receive either rapid intermittent bolus or slow continuous infusion management with hypertonic saline. The primary outcome is the incidence of overcorrection at any given period over 2 days. The secondary outcomes will include the efficacy and safety of two other approaches to the treatment of hyponatremia with 3% hypertonic saline.

Discussion: This is the first clinical trial to investigate the efficacy and safety of rapid intermittent correction compared with slow continuous correction with hypertonic saline in patients with moderately severe or severe hyponatremia.

Trial registration: ClinicalTrials.gov, identifier number: NCT02887469 . Registered on 1 August 2016.

Keywords: Hypertonic saline; Hyponatremia; Osmotic demyelination syndrome; Treatment.

Figures

Fig. 1
Fig. 1
Study algorithm. ER emergency room
Fig. 2
Fig. 2
Schedule of enrollment, interventions, and assessments according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guideline. GCS Glasgow Coma Scale
Fig. 3
Fig. 3
Study schedule. R randomization, ER emergency room, CBC complete blood count, Glu glucose, AST aspartate aminotransferase, ALT alanine aminotransferase, Chol cholesterol, BUN blood urea nitrogen, Cr creatinine, tCO2 total CO2, TFT thyroid function test, ACTH rapid adrenocorticotropic hormone, Osm Osmolality, U/A urinalysis, E' electrolyte, UOsm Urine osmolality, GCS Glasgow Coma Scale
Fig. 4
Fig. 4
Treatment. a Rapid intermittent correction with hypertonic saline in patients with moderately severe or severe symptomatic hyponatremia. min minute, Na sodium, bwt body weight. ↑, increase. b Slow continuous correction with hypertonic saline in patients with moderately severe or severe symptomatic hyponatremia. hr hour, Na sodium, bwt body weight. ↑, increase; Δ, delta – change in amount

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