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01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Trials 1/2017

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)

Zeitschrift:
Trials > Ausgabe 1/2017
Autoren:
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
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​s13063-017-1865-z) contains supplementary material, which is available to authorized users.

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.
Zusatzmaterial
Additional file 1: SPIRIT 2013 Checklist: recommended items to address in a clinical protocol and related documents. (DOC 122 kb)
13063_2017_1865_MOESM1_ESM.doc
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