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

  • STATUS
    Recruiting
  • days left to enroll
    5
  • participants needed
    40
  • sponsor
    Rajavithi Hospital
Updated on 5 March 2021

Summary

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

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.

Details
Condition Hyponatremia, Low Blood Sodium (Hyponatremia), Osmotic Demyelination Syndrome
Treatment 3%NaCl
Clinical Study IdentifierNCT04561531
SponsorRajavithi Hospital
Last Modified on5 March 2021

Eligibility

Yes No Not Sure

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
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