Evidence map›Paper›PMID 28356136›Full record

Trial reportTrials2017

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 and 2 more

2 registry-linked trialsAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02887469 phase4completednot on this map

Efficacy and Safety of Rapid Intermittent Correction Compared With Slow Continuous Correction With Hypertonic Saline in Patient With Moderately Severe or Severe Symptomatic Severe Hyponatremia (SALSA Trial)

TypeinterventionalSponsorSeoul National University HospitalRan2016 to 2019Enrolled178ConditionsHyponatremia SymptomaticArms3% hypertonic saline
NCT04561531 naunknown statusnot on this mapstarted 2020, after this paper: background citation

Efficacy and Safety of Intermittent Bolus Comparing With Traditional Continuous Drip of 3% NaCl in Patients With Severe Symptomatic Hyponatremia at Rajavithi Hospital

TypeinterventionalSponsorDepartment of Medical Services Ministry of Public Health of ThailandRan2020 to 2021Enrolled40ConditionsHyponatremia, Osmotic Demyelination SyndromeArms3%NaCl
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Interventions for chronic non-hypovolaemic hypotonic hyponatraemia.The Cochrane database of systematic reviews · 2018
    Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Article
  8. Treatment of Severe Hyponatremia.Clinical journal of the American Society of Nephrology : CJASN · 2018
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Anna LeeDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
You Hwan JoDepartment of Emergency Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
Kyuseok KimDepartment of Emergency Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
Soyeon AhnDepartment of Medical Research Collaborating Center, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
Yun Kyu OhDepartment of Internal Medicine, Seoul National University Boramae Hospital, Seoul, Republic of Korea.
Huijai LeeDepartment of Emergency Medicine, Seoul National University Boramae Hospital, Seoul, Republic of Korea.
Jonghwan ShinDepartment of Emergency Medicine, Seoul National University Boramae Hospital, Seoul, Republic of Korea.
Ho Jun ChinDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
Ki Young NaDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
Jung Bok LeeClinical Epidemiology and Biostatistics, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea.
Seon Ha BaekDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea. seonhabaek@hallym.or.kr.ORCID 0000-0002-4751-9817
Sejoong KimDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea. sejoong@snubh.org.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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. 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 registrationClinicalTrials.gov, identifier number: NCT02887469 . Registered on 1 August 2016.

Indexed as

BiomarkersClinical ProtocolsFluid TherapyHumansHyponatremiaInfusions, IntravenousProspective StudiesRepublic of KoreaResearch DesignSaline Solution, HypertonicSeverity of Illness IndexSodiumTime FactorsTreatment OutcomeBiomarkersSaline Solution, HypertonicSodiumHypertonic salineHyponatremiaOsmotic demyelination syndromeTreatment

Identifiers

PMID28356136
PMCPMC5372334

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.