Hyponatremia, Osmotic Demyelination Syndrome
Conditions
Brief summary
To compare between intermittent bolus and traditional continuous drip of 3%NaCl in patients with severe symptomatic hyponatremia in Rajavithi Hospital.
Detailed description
Background: Hyponatremia is the most common electrolyte imbalance in clinical practice, associated with increased mortality and length of stay. In 2014,European guideline have recommended promp infusion of 3%NaCl 150 ml in 20 minutes to raise plasma Na to 5 mmol/L and improve symptoms. The recommendation was the result of studies with small numbers of patients, and expert opinions. Methods: A single center opened-label randomized controlled-trial,we will randomly assign 40 patients with severe symptomatic hyponatremia (plasmaNa\<125mmol/L) in Rajavithi Hospital into two groups: First group receive intermittent bolus of 3%NaCl 150 ml in 30 minutes and follow plasma sodium until achieve target of goal plasma sodium = 5 mmol/L in 6 hours (no more than 12 mmol/L in 24 hr and 18 mmol/L in 48 hr),another receive traditional continuous drip of 3%NaCl start with rate = 1ml/kg/hr and follow plasma sodium every 1 hour until achieve target of plasma sodium 5 mmol/L in 6 hours .The primary end point is change in plasma sodium in 6 hours and improvement of glasglow coma scale.The secondary end points are change in plasma sodium in 24,48 hours,overcorrection rate in 24 and 48 hours ,ODS rate ,hospitality days and mortality rate.
Interventions
OTHER3%NaCl
Intervention is infusion of 3%NaCl which is defined in arms of experiment.
Sponsors
Department of Medical Services Ministry of Public Health of Thailand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients in Rajavithi Hospital * Age from 18 years * Plasma Na \< 125 mmol/l with glucose-corrected * Severe symptomatic hyponatremia (Vomitting ,Coma ,Somnolence)
Exclusion criteria
* Systolic BP \< 90 mmHg Or MAP\< 70 mmHg * Pregnancy or Lactation * Congestive Heart Failure or Volume overload * Lung congestionfrom CXR * Chronic renal failure patients with edema * Cirrhosis patients with edema * Patients with coronary artery disease * Patients with brain injuries * Deny consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma sodium and glasglow coma scale(GCS) | 6 hours | Change in plasma sodium and level of consciousness (GCS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma sodium and glasglow coma scale(GCS) | 24 and 48 hours | Change in plasma sodium and level of consciousness (GCS) |
| overcorrection rate | 24 and 48 hours | rate of overcorrection which defined as change in plasma sodium over 12 mmol/L in 24 hr and 18 mmol/L in 48 hr |
| ODS rate | in 7 days | rate of osmotic demyelinating syndrome |
| hospitality days | until discharge | hospitality days |
| mortality rate | in 30 days | mortality rate |
Countries
Thailand
Contacts
Primary ContactOrakan Lanwong
Backup ContactKumtorn Lelamali
Outcome results
None listed