Clinical trial NCT02733549: Is The Sudden Onset of Dizziness A Symptom of Acute Liver Dysfunction?
Official title: Is The Sudden Onset of Dizziness A Symptom of Acute Liver Dysfunction?An ED Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dizziness
Lead sponsor: Adiyaman University Research Hospital
Sponsor class: OTHER
First posted: 2016-04-11
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with sudden onset dizziness admitted to emergency department.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: LFTs serum levels by biochemical method ALT, AST, ALP, GGT, total bilirubin, conjugated bilirubin, albumin, INR, aPTT, and Platelet count (PC)
timeFrame: 5 months
Secondary outcomes:
measure: The cost calculation for the LFTs
timeFrame: 5 months
Other outcomes:
Locations:
city: Adiyaman
country: Turkey
facility: Adiyaman University Research Hospital
state: Central
Study officials:
affiliation: Adiyaman University Medical Faculty
name: Umut Gulacti
role: PRINCIPAL_INVESTIGATOR
References:
citation: Giannini EG, Testa R, Savarino V. Liver enzyme alteration: a guide for clinicians. CMAJ. 2005 Feb 1;172(3):367-79. doi: 10.1503/cmaj.1040752.
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.