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

Not Applicable

• Conditions: Hyponatremia; Osmotic Demyelination Syndrome
• Interventions: Other: 3%NaCl

• Registration Number: NCT04561531
• Lead Sponsor: Rajavithi Hospital

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.

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-28
• Study First Submitted QC: 2020-09-17
• Study First Posted: 2020-09-23
• Study Start: 2020-09-30
• Last Update Submitted: 2021-02-24
• Last Update Posted: 2021-02-25
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients in Rajavithi Hospital
• Age from 18 years
• Plasma Na < 125 mmol/l with glucose-corrected
• Severe symptomatic hyponatremia (Vomitting ,Coma ,Somnolence)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intermittent bolus	3%NaCl	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.
Traditional continuous drip	3%NaCl	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.

Primary Outcome Measures

Name	Time	Method
Plasma sodium and glasglow coma scale(GCS)	6 hours	Change in plasma sodium and level of consciousness (GCS)

Secondary Outcome Measures

Name	Time	Method
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
mortality rate	in 30 days	mortality rate
hospitality days	until discharge	hospitality days
ODS rate	in 7 days	rate of osmotic demyelinating syndrome

Trial Locations

Locations (1)

Rajavithi Hospital; 🇹🇭 Bangkok, Thailand