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

Last updated: February 24, 2021
Sponsor: Rajavithi Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Multiple Sclerosis

Neurologic Disorders

Hyponatremia

Treatment

N/A

Clinical Study ID

NCT04561531
148/2563
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 40
Study Start date:
September 30, 2020
Estimated Completion Date:
September 30, 2021

Study 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.

Connect with a study center

  • Rajavithi Hospital

    Bangkok, 10400
    Thailand

    Active - Recruiting

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