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Sodium Bicarbonate for Acute Peripheral Vertigo

Primary Purpose

Peripheral Vertigo

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Diphenhydramine
Sodium Bicarbonate
Diphenhydramine + Sodium Bicarbonate
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Vertigo focused on measuring Sodium Bicarbonate, Diphenhydramine

Eligibility Criteria

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

Inclusion Criteria: Patients with acute onset vertigo Exclusion Criteria: Pregnancy First vertigo episode over 24 hours Using any anti-vertigo medicine after onset Drug allergy to Sodium bicarbonate or Diphenhydramine Diagnosed with central vertigo Heart failure NYHA class >1 Chronic kidney disease (CKD) stage ≥ 3

Sites / Locations

  • National Taiwan University Yunlin BranchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Diphenhydramine

Sodium Bicarbonate

Diphenhydramine with Sodium Bicarbonate

Arm Description

Diphenhydramine 30 mg in 100 mL normal saline intravenous dripping

Sodium bicarbonate 66.4 mEq in 100 mL normal saline intravenous dripping

Diphenhydramine 30 mg in 100 mL normal saline intravenous dripping with Sodium bicarbonate 66.4 mEq intravenous push

Outcomes

Primary Outcome Measures

Reduction in vertigo intensity
Reduction in Vertigo Visual Analog Scale (VAS 0~10, higher scores mean higher intensity) from baseline

Secondary Outcome Measures

Reduction in nausea intensity
Reduction in Nausea Visual Analog Scale (VAS 0~10, higher scores mean higher intensity) from baseline
Improvement of ambulatory ability
Change in objective ambulatory ability (score 1~4, higher scores mean a worse outcome) from baseline
Lethargy
Lethargy score (score 1~4, 1 indicates no lethargy and 4 indicates very lethargy)
Emergency Department staying time
From patients admit to Emergency Department until patients discharge (up to 24 hours)

Full Information

First Posted
December 12, 2022
Last Updated
July 10, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05676216
Brief Title
Sodium Bicarbonate for Acute Peripheral Vertigo
Official Title
Efficacy of Sodium Bicarbonate for Treatment of Acute Peripheral Vertigo: A Double-blinded Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 7, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Vertigo is defined as the hallucination of spinning sensation or rotatory movement and is frequently combined with severe nausea and vomiting. In Taiwan, an average of 3.13 cases per 100 persons suffer from acute vertigo attack per year. And 1 in 3 patients with vertigo will have recurrent attack within a year. The sensation of disequilibrium and severe nausea and vomiting urge patients visit emergent department (ED) for help. Therefore, vertigo is one of the most common complaints in ED. Vertigo can be divided into central type and peripheral type. Central type vertigo included life threatening disease like brainstem hemorrhage or infraction. Although peripheral vertigo is mostly benign, the acute symptoms relief are usually needed. The first line therapy of acute peripheral vertigo is using antihistamine or benzodiazepine with other anti-emetic agents. However, these agents usually have side effects of fatigue and lethargy, which will cause increasing patients' length of stay or elders' risk of falling. Sodium bicarbonate is widely used in treating hyperkalemia or metabolic acidosis. Its safety and no side effect have also been proved. There were few reports of using sodium for treatment of acute vertigo in Taiwan and Japan. However, there is no strong evidence of comparing this therapy with other medication. This study hypothesized that there is an equivalence of efficacy between sodium bicarbonate and diphenhydramine for treatment of vertigo. Using sodium can cause less fatigue or lethargy and can decrease ED length of stay. This study aims to perform a double-blinded randomized controlled trial to evaluate the efficacy of sodium bicarbonate for treatment of acute peripheral vertigo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Vertigo
Keywords
Sodium Bicarbonate, Diphenhydramine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
225 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diphenhydramine
Arm Type
Active Comparator
Arm Description
Diphenhydramine 30 mg in 100 mL normal saline intravenous dripping
Arm Title
Sodium Bicarbonate
Arm Type
Experimental
Arm Description
Sodium bicarbonate 66.4 mEq in 100 mL normal saline intravenous dripping
Arm Title
Diphenhydramine with Sodium Bicarbonate
Arm Type
Experimental
Arm Description
Diphenhydramine 30 mg in 100 mL normal saline intravenous dripping with Sodium bicarbonate 66.4 mEq intravenous push
Intervention Type
Drug
Intervention Name(s)
Diphenhydramine
Intervention Description
Diphenhydramine 30 mg in 100 mL normal saline intravenous dripping when vertigo patients visit Emergency Department
Intervention Type
Drug
Intervention Name(s)
Sodium Bicarbonate
Intervention Description
Sodium bicarbonate 66.4 mEq in 100 mL normal saline intravenous dripping when vertigo patients visit Emergency Department
Intervention Type
Drug
Intervention Name(s)
Diphenhydramine + Sodium Bicarbonate
Intervention Description
Diphenhydramine 30 mg in 100 mL normal saline intravenous dripping with Sodium bicarbonate 66.4 mEq intravenous push when vertigo patients visit Emergency Department
Primary Outcome Measure Information:
Title
Reduction in vertigo intensity
Description
Reduction in Vertigo Visual Analog Scale (VAS 0~10, higher scores mean higher intensity) from baseline
Time Frame
Baseline and 60 minutes after drug administration
Secondary Outcome Measure Information:
Title
Reduction in nausea intensity
Description
Reduction in Nausea Visual Analog Scale (VAS 0~10, higher scores mean higher intensity) from baseline
Time Frame
Baseline and 60 minutes after drug administration
Title
Improvement of ambulatory ability
Description
Change in objective ambulatory ability (score 1~4, higher scores mean a worse outcome) from baseline
Time Frame
Baseline and 60 minutes after drug administration
Title
Lethargy
Description
Lethargy score (score 1~4, 1 indicates no lethargy and 4 indicates very lethargy)
Time Frame
60 minutes after drug administration
Title
Emergency Department staying time
Description
From patients admit to Emergency Department until patients discharge (up to 24 hours)
Time Frame
up to 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with acute onset vertigo Exclusion Criteria: Pregnancy First vertigo episode over 24 hours Using any anti-vertigo medicine after onset Drug allergy to Sodium bicarbonate or Diphenhydramine Diagnosed with central vertigo Heart failure NYHA class >1 Chronic kidney disease (CKD) stage ≥ 3
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chien-Yu Chi, MD
Phone
+886 0972655833
Email
Y06108@ms1.ylh.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chien-Yu Chi, MD
Organizational Affiliation
Emergency Department, National Taiwan University, Yunlin Branch
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Yunlin Branch
City
Yunlin County
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chien-Yu Chi, MD
Phone
+886 0972655833
Email
Y06108@ms1.ylh.gov.tw

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35849408
Citation
Hunter BR, Wang AZ, Bucca AW, Musey PI Jr, Strachan CC, Roumpf SK, Propst SL, Croft A, Menard LM, Kirschner JM. Efficacy of Benzodiazepines or Antihistamines for Patients With Acute Vertigo: A Systematic Review and Meta-analysis. JAMA Neurol. 2022 Sep 1;79(9):846-855. doi: 10.1001/jamaneurol.2022.1858.
Results Reference
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PubMed Identifier
30845218
Citation
Numata K, Shiga T, Omura K, Umibe A, Hiraoka E, Yamanaka S, Azuma H, Yamada Y, Kobayashi D. Comparison of acute vertigo diagnosis and treatment practices between otolaryngologists and non-otolaryngologists: A multicenter scenario-based survey. PLoS One. 2019 Mar 7;14(3):e0213196. doi: 10.1371/journal.pone.0213196. eCollection 2019.
Results Reference
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Sodium Bicarbonate for Acute Peripheral Vertigo

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