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

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ClinicalTrials.gov Identifier: NCT02733549
Recruitment Status : Completed
First Posted : April 11, 2016
Last Update Posted : April 12, 2016
Sponsor:
Information provided by (Responsible Party):
Umut Gulacti, Adiyaman University Research Hospital

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.

Condition or disease Intervention/treatment
Dizziness Other: LFTs

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 198 participants
Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Is The Sudden Onset of Dizziness A Symptom of Acute Liver Dysfunction?An ED Study
Study Start Date : September 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
patient
Patients with sudden onset dizziness (SOD) analysed LFTs
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.

Other Name: liver function tests

control
The control group with 98 healthy volunteer analysed LFTs
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.

Other Name: liver function tests




Primary Outcome Measures :
  1. LFTs serum levels by biochemical method ALT, AST, ALP, GGT, total bilirubin, conjugated bilirubin, albumin, INR, aPTT, and Platelet count (PC) [ Time Frame: 5 months ]
    The serum levels of LFTs will obtained by the laboratory analysis of blood samples of each participant.


Secondary Outcome Measures :
  1. The cost calculation for the LFTs [ Time Frame: 5 months ]
    The cost for the LFTs will be calculated with financial data in invoices which will obtained from the hospital invoicing service.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Adult patients with sudden onset dizziness admitted to emergency department.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02733549


Locations
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Turkey
Adiyaman University Research Hospital
Adiyaman, Central, Turkey, 02000
Sponsors and Collaborators
Adiyaman University Research Hospital
Investigators
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Principal Investigator: Umut Gulacti Adiyaman University Medical Faculty

Additional Information:

Publications:
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Responsible Party: Umut Gulacti, principal investigator, Adiyaman University Research Hospital
ClinicalTrials.gov Identifier: NCT02733549     History of Changes
Other Study ID Numbers: ADYU-4
First Posted: April 11, 2016    Key Record Dates
Last Update Posted: April 12, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Dizziness
Vertigo
Liver Diseases
Sensation Disorders
Neurologic Manifestations
Signs and Symptoms
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Nervous System Diseases
Digestive System Diseases