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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 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.



Original Primary Outcome: Incidence of overcorrection rate at any given period [ Time Frame: up to 48 hours ]

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


Current Secondary Outcome:

  • Rapid improvement of symptoms [ Time Frame: up to 24 hours ]
    Change of symptoms from baseline to 24 hours after hypertonic fluid treatment
  • Time from treatment initiation to an increase of serum Na ≥ 5 mmol/L [ Time Frame: up to 48 hours ]
  • Incidence of target correction rate [ Time Frame: up to 48 hours ]
    Target correction rate is defined by achieved serum Na <10 mmol/L within 24 hours, achieved serum Na <18 mmol/L within 48 hours
  • Time to serum Na >130 mmol/L [ Time Frame: up to 48 hours ]
    Time from treatment initiation to achieved serum Na> 130mmol/L
  • Length of hospital stay [ Time Frame: up to 8 weeks ]
  • Incidence of additional treatment [ Time Frame: up to 48 hours ]
    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)
  • Incidence of osmotic demyelinating syndrome confirmed by ICD -10 code or MRI [ Time Frame: up to 48 hours ]
  • Incidence of relowering treatment [ Time Frame: up to 48 hours ]

    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
  • Change of Glasgow coma scale (GCS) ≤8 [ Time Frame: up to 48 hours ]
    Change in GCS of hyponatremia symptoms at pretreatment, 24 hours, and 48 hours after treatment


Original Secondary Outcome:

  • Rapid improvement of symptoms [ Time Frame: up to 24hr ]
    Change of symptoms from baseline to 24hr after hypertonic fluid treatment
  • Time from treatment initiation to an increase of serum Na ≥ 5 mmol/L [ Time Frame: up to 48hr ]
  • Incidence of target correction rate [ Time Frame: up to 48hr ]
    Target correction rate is defined by achieved serum Na <10 mmol/L within 24hr, achieved serum Na <18 mmol/L within 48hr
  • Time to serum Na >130 mmol/L [ Time Frame: up to 48hr ]
    Time from treatment initiation to achieved serum Na> 130mmol/L
  • Length of hospital stay [ Time Frame: up to 8wks ]
  • Incidence of additional treatment [ Time Frame: up to 48hr ]
    Additional treatment is performed if symptom is not relieved or undercorrection develops (achieved Na < 5mmol/L with 24hr or achieved Na <12mmol/L within 48hr)
  • Incidence of osmotic demyelinating syndrome confirmed by ICD -10 code or MRI [ Time Frame: up to 48hr ]
  • Incidence of relowering treatment [ Time Frame: up to 48hr ]

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

    1. discontinuing ongoing active treatment
    2. start infusion of 10ml/kg of 5DW over 1hr ± desmopressin 2mcg IV
  • Change of Glasgow coma scale (GCS) ≤8 [ Time Frame: up to 48hr ]
    Change in GCS of hyponatremia symptoms at pretreatment, 24hr, and 48hr after treatment


Information By: Seoul National University Hospital

Dates:
Date Received: August 1, 2016
Date Started: August 2016
Date Completion: July 2018
Last Updated: February 5, 2017
Last Verified: February 2017