• Trials · Mar 2017

    Randomized Controlled Trial Multicenter Study Comparative Study

    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, and Sejoong Kim.
    • Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
    • Trials. 2017 Mar 29; 18 (1): 147.

    BackgroundHyponatremia 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/DesignThis 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.DiscussionThis 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 RegistrationClinicalTrials.gov, identifier number: NCT02887469 . Registered on 1 August 2016.

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