NCT02733549

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 11, 2016

Completed
Last Updated

April 12, 2016

Status Verified

April 1, 2016

Enrollment Period

6 months

First QC Date

March 27, 2016

Last Update Submit

April 9, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • The cost calculation for the LFTs

    5 months

Study Arms (2)

patient

Patients with sudden onset dizziness (SOD) analysed LFTs

Other: LFTs

control

The control group with 98 healthy volunteer analysed LFTs

Other: LFTs

Interventions

LFTsOTHER

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.

Also known as: liver function tests
controlpatient

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Adult patients with sudden onset dizziness admitted to emergency department.

You may qualify if:

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

You may not qualify if:

  • Patients with a history of chronic diseases such as any liver disease,diabetes mellitus, hypertension,congestive heart failure, hepatitis B or C infection
  • Patients with any central dizziness attacks
  • Patients with hemodynamically unstable and emesis;
  • 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)
  • Patients who was experienced dizziness with systemic diseases
  • Patients with any neurological disorders
  • Patient who do not want to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adiyaman University Research Hospital

Adıyaman, Central, 02000, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 15684121BACKGROUND
  • 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.

    PMID: 18613993BACKGROUND

MeSH Terms

Conditions

Dizziness

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Umut Gulacti

    Adiyaman University Medical Faculty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 27, 2016

First Posted

April 11, 2016

Study Start

September 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

April 12, 2016

Record last verified: 2016-04

Locations