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 ]
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.
- discontinuing ongoing active treatment
- 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.
- discontinuing ongoing active treatment
- 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