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

• Sponsor: Rajavithi Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04561531
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• Anticipated 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: Sep 30, 2020
• Anticipated Primary Completion Date: Sep 30, 2021
• Anticipated Study Completion Date: Sep 30, 2021

Arms and Interventions

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

Primary Outcome Measures

1. Plasma sodium and glasglow coma scale(GCS) [6 hours]

   Change in plasma sodium and level of consciousness (GCS)

Secondary Outcome Measures

1. Plasma sodium and glasglow coma scale(GCS) [24 and 48 hours]

   Change in plasma sodium and level of consciousness (GCS)

2. 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

3. ODS rate [in 7 days]

   rate of osmotic demyelinating syndrome

4. hospitality days [until discharge]

   hospitality days

5. mortality rate [in 30 days]

   mortality rate

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Rajavithi Hospital	Bangkok		Thailand	10400

Sponsors and Collaborators

• Rajavithi Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• 7. Mohamed OH, Abdallah N. Prevention and treatment of the osmotic demyelination syndrome: JSM Brain Sci 2016; 1: 1004.
• 14. Lambeck J, Hieber M, Dreßing A, Niesen WD. Central pontine myelinolysis and osmotic demyelination syndrome. Dtsch Arztebl Int. 2019; 116: 600-6.

Publications

• King JD, Rosner MH. Osmotic demyelination syndrome. Am J Med Sci. 2010 Jun;339(6):561-7. doi: 10.1097/MAJ.0b013e3181d3cd78. Review.

• Responsible Party: Rajavithi Hospital
• ClinicalTrials.gov Identifier: NCT04561531
• Other Study ID Numbers: 148/2563
• First Posted: Sep 23, 2020
• Last Update Posted: Feb 25, 2021
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Demyelinating Diseases; Hyponatremia

Study Results

No Results Posted as of Feb 25, 2021