Is The Sudden Onset of Dizziness A Symptom of Acute Liver Dysfunction?

Dizziness Clinical Trial

Official title:

Is The Sudden Onset of Dizziness A Symptom of Acute Liver Dysfunction?An ED Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02733549
• Other study ID #: ADYU-4
• Status: Completed
• Phase: N/A
• First received: March 27, 2016
• Last updated: April 9, 2016
• Start date: September 2012
• Est. completion date: March 2013

Study information

• Verified date: April 2016
• Source: Adiyaman University Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Dizziness is one of the most common complaints among patients admitted to the emergency department (ED). In most cases, the etiology remains unclear. Dizziness has a broad differential diagnosis. The initial symptoms of ALD can include many general complaints. Aim of this study is to investigate whether SOD is a symptom of ALD, the necessity of liver function tests for patients with SOD in the ED, and a cost analysis of liver function tests.

Description:

Dizziness is one of the most common complaints among patients admitted to the emergency department (ED). In most cases, the etiology remains unclear. Dizziness has a broad differential diagnosis. The initial symptoms of ALD can include many general complaints. The diagnosis of acute liver dysfunction (ALD) can usually be made by initial symptoms, physical examination, and biochemical tests, including liver function tests (LFTs) with high sensitivity and specificity. LFTs include albumin, bilirubin, coagulation factors (Activated Partial Thromboplastin Time (aPTT) and International Normalized Ratio (INR)), and liver enzymes, such as alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphates (ALP), and y-glutamyl transpeptidase (GGT), which are marker of hepatic damage. Aim of this study is to investigate whether SOD is a symptom of ALD, the necessity of LFTs for patients with SOD in the ED, and a cost analysis of LFTs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Adult patients who were experiencing sudden onset dizziness of unknown etiology for the first time were included in the study

Exclusion Criteria:

1. Patients with a history of chronic diseases such as any liver disease,diabetes mellitus, hypertension,congestive heart failure, hepatitis B or C infection

2. Patients with any central dizziness attacks

3. Patients with hemodynamically unstable and emesis;

4. Patients receiving drugs that could affect liver function tests, such as, acetaminophen, antibiotics, oral contraceptives, antihypertensive drugs (e.g., angiotensinconverting enzyme inhibitors), or hormones (e.g.,estrogen)

5. Patients who was experienced dizziness with systemic diseases

6. Patients with any neurological disorders

7. Patient who do not want to participate in the study

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dizziness
• Vertigo

Intervention

Other:
• LFTs
A single 5-ml peripheral venous blood sample was collected from each participant. Serum ALT, AST, ALP, GGT, total bilirubin, conjugated bilirubin, and albumin level, Platelet count, INR and aPTT were analyzed.

Locations

Country	Name	City	State
Turkey	Adiyaman University Research Hospital	Adiyaman	Central

Sponsors (1)

Lead Sponsor	Collaborator
Adiyaman University Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Giannini EG, Testa R, Savarino V. Liver enzyme alteration: a guide for clinicians. CMAJ. 2005 Feb 1;172(3):367-79. Review. — View Citation

Newman-Toker DE, Hsieh YH, Camargo CA Jr, Pelletier AJ, Butchy GT, Edlow JA. Spectrum of dizziness visits to US emergency departments: cross-sectional analysis from a nationally representative sample. Mayo Clin Proc. 2008 Jul;83(7):765-75. doi: 10.4065/83.7.765. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LFTs serum levels by biochemical method ALT, AST, ALP, GGT, total bilirubin, conjugated bilirubin, albumin, INR, aPTT, and Platelet count (PC)	The serum levels of LFTs will obtained by the laboratory analysis of blood samples of each participant.	5 months	No
Secondary	The cost calculation for the LFTs	The cost for the LFTs will be calculated with financial data in invoices which will obtained from the hospital invoicing service.	5 months	No