AzTrials
AzTrials

Hyponatremia SymptomaticPhase 4NCT02887469

Efficacy and Safety of Rapid Intermittent Compared With Slow Continuous Correction in Severe Hyponatremia Patients

A Phase 4 study testing 3% hypertonic saline in people with Hyponatremia Symptomatic, run by Seoul National University Hospital at 3 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will investigate 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hyponatremia Symptomatic
What is being tested?
3% hypertonic saline
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
178 participants
Where
3 sitesSouth Korea
Study dates
Aug 2016to 30 Sep 2019
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • In emergency setting (2016.6-) and/or inpatients at ward (2018.9-)
  • Glucose corrected serum sodium ≤125 mmol/L
  • Patients with moderately severe or severe symptom
  • Moderately severe
  • :Nausea without vomiting Drowsy, Headache General weakness, myalgia
  • Severe :Vomiting, Stupor, Seizures, Coma (Glasgow Coma Scale ≤8)
  • written consent

Who cannot join

  • Pseudohyponatremia: serum osmolality > 275 mOsm/kg
  • If the serum osmolality is > 275 mOsm/kg but the BUN is ≥ 30 mg/dL, the patients can be registered if calculated serum osmolality (2 x plasma [Na] + [Glucose]/18) is <275 mOsm/kg
  • Primary polydipsia: urine osmolality ≤ 100 mOsm/kg
  • Glucose corrected serum sodium >125 mmol/L
  • Arterial hypotension (SBP <90mmHg and MAP <70mmHg)
  • Anuria or urinary outlet obstruction
Show all 12Show fewer
  • Liver disease
  • transaminase levels >3 times the upper limit normal
  • Known LC with ascites or diuretics use or PSE Hx or Varix Hx
  • Uncontrolled diabetes mellitus (HbA1C > 9%)
  • Women who are pregnant or breast feeding
  • History of cardiac surgery excluding PCA, acute myocardial infarction, sustained ventricular tachycardia, ventricular fibrillation, acute coronary syndrome, cebrovascular trauma, and increased intracranial pressure within the 3 months prior to randomization

Trial locations and contacts

3 sites in 1 country.

South Korea3 sites

  • Hallym University Dongtan Sacred Hospital

    Hwaseong-si, Gyeonggi-do, 445-907

  • Seoul National University Bundang Hospital Clinical Trial Center

    Seongnam-si, Gyeonggi-do, 13605

  • Seoul National University Boramae Hospital

    Seoul

Other trials in South Korea

About this study

Official title: 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)

This study will investigate 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

Read the detailed description

Moderate to severe symptomatic hyponatremia requires prompt treatment with hypertonic saline. The extent and rate of increase in serum sodium (sNa) levels during treatment are critical. Several methods for continuous infusion of hypertonic saline were used to guide rate of fluid administered to achieve the required serum sodium target. As based on static model, they had a bias to over-correction of hyponatremia. Alternative approach to treatment with hypertonic fluid is to use small, fixed boluses to achieve controlled increments in sNa. However, there was no high quality evidence on whether hypertonic saline are best given in continuous infusion (preferred by most) or bolus injection. The aim of present study, a multi-center (Seoul National University Bundang Hospital [2016.8~], Seoul National University Boramae Medical Center [2016. 9~], Hallym University Dongtan Sacred Heart Hospital [2017.7~]), randomized, open labelled, controlled clinical trial, is to investigate 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. A total 178 patients, who suffer from symptomatic severe hyponatremia, will be enrolled and randomly assigned to receive either intermittent bolus infusion or slow continuous infusion by 3% hypertonic saline. Subjects will take different rate of 3% hypertonic saline for 24-48 hours stratified by severity of clinical symptoms. Serum sodium will be measured at every six hours during two days.

Being tested
3% hypertonic saline
Keywords
Hyponatremia, Hypertonic saline, Treatment, Osmotic demyelination syndrome
Medical subject headings
Hyponatremia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3% hypertonic salineDrug

    The same as above

Study groups in NCT02887469
Study groupRoleWhat they receive
Intermittent bolus groupActive comparator<<Within 6hr>> * Moderately Severe : 3% saline 2ml/kg over 20min *1 (unknown bwt 100ml) * Severe :3% saline 2ml/kg over 20min *2 (unknown bwt 100ml) <additional treatment> Repeat 3% saline 2ml/kg over 20min at every sample time point (at 1/6hr) till Na 5-9 mmol/L inc from initial Na and sx relief <<During 6-24hr>> - Moderately Severe or Severe : Repeat 3% saline 2ml/kg over 20min at every sample time point(at 12/18/24hr) till Na 5-9 mmol/L inc from initial Na and sx relief <<During 24-48hr>> * Moderately Severe or Severe : Repeat 3% saline 2ml/kg over 20min at every sample time point (at 30/36/42/48hr) till Na 10-17 mmol/L inc from initial Na or Na ≥ 130mmol and sx relief
Receives: Drug: 3% hypertonic saline
slow continuous infusion groupActive comparator<<Within 24hr>> - Moderately Severe: 3% saline 0.5ml/kg/hr (unknown bwt 25ml/hr) - Severe: 3% saline 1ml/kg/hr (unknown bwt 50ml/hr) Infusion protocol modification as below by Na at every sample time point (at 1/6/12/18/24 hr) If Na 5-9 mmol/L inc from initial Na and sx relief : stop 3% saline infusion regardless of △ Na if △ Na inc <0.5mmol/hr or △ Na inc <3mmol/6hr : add 0.25ml/kg/hr, restart 0.5ml/kg/hr if previously stopped if △ Na inc ≥0.5mmol/hr or △ Na inc ≥ 3mmol/6hr : maintain infusion rate <<During 24-48hr>> - Moderately Severe and Severe Infusion protocol modification as below by Na at every sample time point (at 30/36/42/48hr) If Na 10-17 mmol/L inc from initial Na or Na ≥ 130mmol and sx relief : stop 3% saline infusion regardless of △ Na if △ Na inc <1.5mmol/6hr : add 0.25ml/kg/hr or restart 0.25ml/kg/hr if previously stopped if △ Na inc ≥ 1.5mmol/6hr : maintain infusion rate
Receives: Drug: 3% hypertonic saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of overcorrection rate at any given period

    Increase in sNa by >12 mmol/L within 24 hours or Increase in sNa by >18 mmol/L within 48 hours All subjects receive hypertonic saline by intermittent bolus or slow continuous infusion for 48 hours, serum Na will be measured.

    Measured: up to 48 hours

Secondary outcomes (9)

  1. Rapid improvement of symptoms

    Change of symptoms from baseline to 24 hours after hypertonic fluid treatment

    Measured: up to 24 hours

  2. Time from treatment initiation to an increase of serum Na ≥ 5 mmol/L

    Measured: up to 48 hours

  3. Incidence of target correction rate

    Target correction rate is defined by achieved serum Na <10 mmol/L within 24 hours, achieved serum Na <18 mmol/L within 48 hours

    Measured: up to 48 hours

  4. Time to serum Na >130 mmol/L

    Time from treatment initiation to achieved serum Na> 130mmol/L

    Measured: up to 48 hours

  5. Length of hospital stay

    Measured: up to 8 weeks

  6. Incidence of additional treatment

    Additional treatment is performed if symptom is not relieved or undercorrection develops (achieved Na < 5mmol/L with 24 hours or achieved Na <12mmol/L within 48 hours)

    Measured: up to 48 hours

  7. Incidence of osmotic demyelinating syndrome confirmed by ICD -10 code or MRI

    Measured: up to 48 hours

  8. Incidence of relowering treatment

    Relowering treatment is performed as below if achieved serum Na is <10 mmol/L within 24 hours, achieved serum Na is <18 mmol/L within 48 hours.

    1. discontinuing ongoing active treatment
    2. start infusion of 10ml/kg of 5% dextrose over 1hr ± desmopressin 2mcg IV

    Measured: up to 48 hours

  9. Change of Glasgow coma scale (GCS) ≤8

    Change in GCS of hyponatremia symptoms at pretreatment, 24 hours, and 48 hours after treatment

    Measured: up to 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2016 (estimated)
  2. Study startAug 2016
  3. Primary completion30 Sep 2019
  4. Study completion30 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
178 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02887469
Sponsor's protocol ID
B1605346003
Status last verified
Apr 2020
First submitted
1 Aug 2016
Last updated
9 Apr 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Spasovski G, Vanholder R, Allolio B, Annane D, Ball S, Bichet D, Decaux G, Fenske W, Hoorn EJ, Ichai C, Joannidis M, Soupart A, Zietse R, Haller M, van der Veer S, Van Biesen W, Nagler E; Hyponatraemia Guideline Development Group. Clinical practice guideline on diagnosis and treatment of hyponatraemia. Eur J Endocrinol. 2014 Feb 25;170(3):G1-47. doi: 10.1530/EJE-13-1020. Print 2014 Mar.

    PubMed 24569125

  • Baek SH, Jo YH, Ahn S, Medina-Liabres K, Oh YK, Lee JB, Kim S. Risk of Overcorrection in Rapid Intermittent Bolus vs Slow Continuous Infusion Therapies of Hypertonic Saline for Patients With Symptomatic Hyponatremia: The SALSA Randomized Clinical Trial. JAMA Intern Med. 2021 Jan 1;181(1):81-92. doi: 10.1001/jamainternmed.2020.5519.

    PubMed 33104189

  • Lee A, Jo YH, Kim K, Ahn S, Oh YK, Lee H, Shin J, Chin HJ, Na KY, Lee JB, Baek SH, Kim S. 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). Trials. 2017 Mar 29;18(1):147. doi: 10.1186/s13063-017-1865-z.

    PubMed 28356136

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 3% hypertonic saline in people with Hyponatremia Symptomatic, run by Seoul National University Hospital at 3 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of overcorrection rate at any given period (time frame: up to 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02887469, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in