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

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ClinicalTrials.gov Identifier: NCT04561531
Recruitment Status : Recruiting
First Posted : September 23, 2020
Last Update Posted : February 25, 2021
Sponsor:
Information provided by (Responsible Party):
Rajavithi Hospital

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

Condition or disease Intervention/treatment Phase
Hyponatremia Osmotic Demyelination Syndrome Other: 3%NaCl Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 30, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Intermittent bolus
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
Intervention is infusion of 3%NaCl which is defined in arms of experiment.
Experimental: Traditional continuous drip
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
Intervention is infusion of 3%NaCl which is defined in arms of experiment.


Outcome Measures
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Primary Outcome Measures :
  1. Plasma sodium and glasglow coma scale(GCS) [ Time Frame: 6 hours ]
    Change in plasma sodium and level of consciousness (GCS)


Secondary Outcome Measures :
  1. Plasma sodium and glasglow coma scale(GCS) [ Time Frame: 24 and 48 hours ]
    Change in plasma sodium and level of consciousness (GCS)

  2. overcorrection rate [ Time Frame: 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

  3. ODS rate [ Time Frame: in 7 days ]
    rate of osmotic demyelinating syndrome

  4. hospitality days [ Time Frame: until discharge ]
    hospitality days

  5. mortality rate [ Time Frame: in 30 days ]
    mortality rate


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04561531


Contacts
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Contact: Orakan Lanwong 0803625252 orakanpor@gmail.com
Contact: Kumtorn Lelamali 0967816239 lelamali01@yahoo.com

Locations
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Thailand
Rajavithi Hospital Recruiting
Bangkok, Thailand, 10400
Sponsors and Collaborators
Rajavithi Hospital
More Information
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Additional Information:

Publications of Results:

Other Publications:

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Responsible Party: Rajavithi Hospital
ClinicalTrials.gov Identifier: NCT04561531    
Other Study ID Numbers: 148/2563
First Posted: September 23, 2020    Key Record Dates
Last Update Posted: February 25, 2021
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Demyelinating Diseases
Hyponatremia
Water-Electrolyte Imbalance
Metabolic Diseases
Nervous System Diseases