Clinical trial NCT04561531: Efficacy and Safety of Bolus Comparing With Continuous Drip of 3% NaCl in Patients With Severe Symptomatic Hyponatremia.
Official title: Efficacy and Safety of Intermittent Bolus Comparing With Traditional Continuous Drip of 3% NaCl in Patients With Severe Symptomatic Hyponatremia at Rajavithi Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyponatremia
Osmotic Demyelination Syndrome
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2020-09-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Plasma sodium and glasglow coma scale(GCS)
timeFrame: 6 hours
Secondary outcomes:
measure: Plasma sodium and glasglow coma scale(GCS)
timeFrame: 24 and 48 hours
measure: overcorrection rate
timeFrame: 24 and 48 hours
measure: ODS rate
timeFrame: in 7 days
measure: hospitality days
timeFrame: until discharge
measure: mortality rate
timeFrame: in 30 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
Study officials:
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