title: 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).
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  ClinicalTrials.gov, identifier number: NCT02887469 . Registered on 1 August 2016.
authors.affiliation: Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
authors.forename: Anna
authors.initials: A
authors.lastname: Lee
authors.affiliation: Department of Emergency Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
authors.forename: You Hwan
authors.initials: YH
authors.lastname: Jo
authors.affiliation: Department of Emergency Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
authors.forename: Kyuseok
authors.initials: K
authors.lastname: Kim
authors.affiliation: Department of Medical Research Collaborating Center, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
authors.forename: Soyeon
authors.initials: S
authors.lastname: Ahn
authors.affiliation: Department of Internal Medicine, Seoul National University Boramae Hospital, Seoul, Republic of Korea.
authors.forename: Yun Kyu
authors.initials: YK
authors.lastname: Oh
authors.affiliation: Department of Emergency Medicine, Seoul National University Boramae Hospital, Seoul, Republic of Korea.
authors.forename: Huijai
authors.initials: H
authors.lastname: Lee
authors.affiliation: Department of Emergency Medicine, Seoul National University Boramae Hospital, Seoul, Republic of Korea.
authors.forename: Jonghwan
authors.initials: J
authors.lastname: Shin
authors.affiliation: Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
authors.forename: Ho Jun
authors.initials: HJ
authors.lastname: Chin
authors.affiliation: Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
authors.forename: Ki Young
authors.initials: KY
authors.lastname: Na
authors.affiliation: Clinical Epidemiology and Biostatistics, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea.
authors.forename: Jung Bok
authors.initials: JB
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea. seonhabaek@hallym.or.kr.|Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong-si, Republic of Korea. seonhabaek@hallym.or.kr.
authors.forename: Seon Ha
authors.identifier: 0000-0002-4751-9817
authors.initials: SH
authors.lastname: Baek
authors.affiliation: Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea. sejoong@snubh.org.
authors.forename: Sejoong
authors.initials: S
authors.lastname: Kim
mesh_terms: D015415:Biomarkers / Q000097:blood; D002985:Clinical Protocols; D005440:Fluid Therapy / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D007010:Hyponatremia / Q000097:blood / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D007262:Infusions, Intravenous; D011446:Prospective Studies; D056910:Republic of Korea; D012107:Research Design; D012462:Saline Solution, Hypertonic / Q000008:administration & dosage* / Q000009:adverse effects; D012720:Severity of Illness Index; D012964:Sodium / Q000097:blood*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D012462:Saline Solution, Hypertonic; D012964:Sodium
keywords: Hypertonic saline; Hyponatremia; Osmotic demyelination syndrome; Treatment