Abstract
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.
Highlights
Hyponatremia is the most common electrolyte imbalance encountered in clinical practice, associated with increased mortality and length of hospital stay
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
The purpose of the present study was to investigate the efficacy and safety of rapid intermittent correction compared with slow continuous correction with hypertonic saline in patients with symptomatic severe hyponatremia
Summary
Hyponatremia is the most common electrolyte imbalance encountered in clinical practice, associated with increased mortality and length of hospital stay. A pragmatic approach to treatment with hypertonic fluid is to use small, fixed boluses to achieve controlled incremental increases in sNa [1, 13,14,15,16,17] This recommendation was the result of small randomized trials [18], case reports with small numbers of patients [14, 19], and expert opinion [20,21,22,23]. The purpose of the present study was to investigate the efficacy and safety of rapid intermittent correction compared with slow continuous correction with hypertonic saline in patients with symptomatic severe hyponatremia. The study will examine prevailing conceptions regarding the optimal treatment of severe symptomatic hyponatremia
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