Efficacy and Safety of Bolus Comparing With Continuous Drip of 3% NaCl in Patients With Severe Symptomatic Hyponatremia.

Study Overview
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Brief Summary
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To compare between intermittent bolus and traditional continuous drip of 3%NaCl in patients with severe symptomatic hyponatremia in Rajavithi Hospital.

Detailed Description
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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.

Official Title
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Efficacy and Safety of Intermittent Bolus Comparing With Traditional Continuous Drip of 3% NaCl in Patients With Severe Symptomatic Hyponatremia at Rajavithi Hospital

Conditions
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Hyponatremia, Osmotic Demyelination Syndrome

Intervention / Treatment
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* Other: 3%NaCl


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intermittent bolus<br>In intermittent bolus of 3%NaCl group ,patients will receive intermittent bolus of 3%NaCl 150 ml in 30 minutes and then follow plasma sodium,observe glasglow coma scale and level of consciousness until improvement of consciousness and achieve target plasma sodium which is 5 mmol/L in 6 hours and should not be overcorrected which defined that plasma sodium change should not be more than 12 mmol/L in 24 hours and 18 mmol/L in 48 hours. | Other: 3%NaCl<br>* Intervention is infusion of 3%NaCl which is defined in arms of experiment.<br>|
| Experimental: Traditional continuous drip<br>In traditional continuous drip of 3%NaCl group ,patients will receive 3%NaCl adjust rate start from 1 ml/kg/hr and follow plasma sodium every 1 hour,observe glasglow coma scale and level of consciousness until improvement of consciousness and achieve target plasma sodium which is 5 mmol/L in 6 hours and should not be overcorrected which defined that plasma sodium change should not be more than 12 mmol/L in 24 hours and 18 mmol/L in 48 hours. | Other: 3%NaCl<br>* Intervention is infusion of 3%NaCl which is defined in arms of experiment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma sodium and glasglow coma scale(GCS) | Change in plasma sodium and level of consciousness (GCS) | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma sodium and glasglow coma scale(GCS) | Change in plasma sodium and level of consciousness (GCS) | 24 and 48 hours | 
| overcorrection rate | rate of overcorrection which defined as change in plasma sodium over 12 mmol/L in 24 hr and 18 mmol/L in 48 hr | 24 and 48 hours | 
| ODS rate | rate of osmotic demyelinating syndrome | in 7 days | 
| hospitality days | hospitality days | until discharge | 
| mortality rate | mortality rate | in 30 days |