DizzinessNCT02733549
Is The Sudden Onset of Dizziness A Symptom of Acute Liver Dysfunction?
An observational study of Dizziness, run by Adiyaman University Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dizziness
- What is being tested?
- LFTs
- How many people
- 198 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2012to Mar 2013
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Adult patients with sudden onset dizziness admitted to emergency department.
Who may be able to join
- 1. Adult patients who were experiencing sudden onset dizziness of unknown etiology for the first time were included in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adiyaman University Research Hospital
Adıyaman, Central, 02000
About this study
Official title: Is The Sudden Onset of Dizziness A Symptom of Acute Liver Dysfunction?An ED Study
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.
Read the 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.
- Conditions
- Dizziness
- Being tested
- LFTs
- Medical subject headings
- Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LFTsOther
Also called liver function tests
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.
| Study group | Role | What they receive |
|---|---|---|
| patient | Patients with sudden onset dizziness (SOD) analysed LFTs Receives: Other: LFTs | |
| control | The control group with 98 healthy volunteer analysed LFTs Receives: Other: LFTs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 months
Secondary outcomes (1)
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.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2016 (estimated)
- Study startSep 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DizzinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 198 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Adiyaman University Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Umut Gulacti, Adiyaman University Research Hospital
- Investigators
- Umut Gulacti, Principal investigator, Adiyaman University Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02733549
- Sponsor's protocol ID
- ADYU-4
- Status last verified
- Apr 2016
- First submitted
- 27 Mar 2016
- Last updated
- 12 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 15684121Newman-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.
PubMed 18613993
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is The Sudden Onset of Dizziness A Symptom of Acute Liver Dysfunction?An ED Study
- ClinicalTrials.gov ID
- NCT02733549
- Acronym / sponsor ID
- ADYU-4
- Conditions
- Dizziness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Adiyaman University Research HospitalUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 11 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient | – | Other: LFTsPatients with sudden onset dizziness (SOD) analysed LFTs |
| control | – | Other: LFTsThe control group with 98 healthy volunteer analysed LFTs |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adult patients with sudden onset dizziness admitted to emergency department.
Key inclusion criteria (1 listed)
- 1. Adult patients who were experiencing sudden onset dizziness of unknown etiology for the first time were included in the study
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LFTsAlso: liver function testsA 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 | control, patient |
Primary outcome
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.
1 secondary outcome
The cost calculation for the LFTs
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2016.
- Background: PubMed 15684121Giannini 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.
- Background: PubMed 18613993Newman-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Umut Gulacti principal investigator
Adiyaman University Medical Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dizziness, run by Adiyaman University Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02733549, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2016.