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

Primary Purpose

Hyponatremia, Osmotic Demyelination Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
3%NaCl
Sponsored by
Rajavithi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyponatremia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rajavithi HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intermittent bolus

Traditional continuous drip

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Plasma sodium and glasglow coma scale(GCS)
Change in plasma sodium and level of consciousness (GCS)

Secondary Outcome Measures

Plasma sodium and glasglow coma scale(GCS)
Change in plasma sodium and level of consciousness (GCS)
overcorrection rate
rate of overcorrection which defined as change in plasma sodium over 12 mmol/L in 24 hr and 18 mmol/L in 48 hr
ODS rate
rate of osmotic demyelinating syndrome
hospitality days
hospitality days
mortality rate
mortality rate

Full Information

First Posted
August 28, 2020
Last Updated
February 24, 2021
Sponsor
Rajavithi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04561531
Brief Title
Efficacy and Safety of Bolus Comparing With Continuous Drip of 3% NaCl in Patients With Severe Symptomatic Hyponatremia.
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 30, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rajavithi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyponatremia, Osmotic Demyelination Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intermittent bolus
Arm Type
Experimental
Arm Description
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.
Arm Title
Traditional continuous drip
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
3%NaCl
Intervention Description
Intervention is infusion of 3%NaCl which is defined in arms of experiment.
Primary Outcome Measure Information:
Title
Plasma sodium and glasglow coma scale(GCS)
Description
Change in plasma sodium and level of consciousness (GCS)
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Plasma sodium and glasglow coma scale(GCS)
Description
Change in plasma sodium and level of consciousness (GCS)
Time Frame
24 and 48 hours
Title
overcorrection rate
Description
rate of overcorrection which defined as change in plasma sodium over 12 mmol/L in 24 hr and 18 mmol/L in 48 hr
Time Frame
24 and 48 hours
Title
ODS rate
Description
rate of osmotic demyelinating syndrome
Time Frame
in 7 days
Title
hospitality days
Description
hospitality days
Time Frame
until discharge
Title
mortality rate
Description
mortality rate
Time Frame
in 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Orakan Lanwong
Phone
0803625252
Email
orakanpor@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kumtorn Lelamali
Phone
0967816239
Email
lelamali01@yahoo.com
Facility Information:
Facility Name
Rajavithi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Citation
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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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