Clinical trial NCT05676216: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Vertigo
Keywords: Sodium Bicarbonate
Diphenhydramine
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-01-09
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Reduction in vertigo intensity
timeFrame: Baseline and 60 minutes after drug administration
Secondary outcomes:
measure: Reduction in nausea intensity
timeFrame: Baseline and 60 minutes after drug administration
measure: Improvement of ambulatory ability
timeFrame: Baseline and 60 minutes after drug administration
measure: Lethargy
timeFrame: 60 minutes after drug administration
measure: Emergency Department staying time
timeFrame: up to 24 hours
Other outcomes:
Locations:
city: Yunlin County
country: Taiwan
facility: National Taiwan University Yunlin Branch
Study officials:
affiliation: Emergency Department, National Taiwan University, Yunlin Branch
name: Chien-Yu Chi, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.