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Trial registered on ANZCTR
Registration number
ACTRN12612000689875
Ethics application status
Not yet submitted
Date submitted
12/12/2011
Date registered
27/06/2012
Date last updated
27/06/2012
Type of registration
Prospectively registered
Titles & IDs
Public title
Prospective study - detecting incidence and recovery of impaired inner ear function with Gentamicin use
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Scientific title
Prospective detection of vestibular abnormalities resulting from the administration of Gentamicin and documentation of their subsequent recovery.
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Secondary ID [1]
273522
0
Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gentamicin vestibulotoxicity
279260
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Sepsis treated with Gentamicin
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Condition category
Condition code
Ear
279467
279467
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0
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Other ear disorders
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Neurological
285563
285563
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0
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Other neurological disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Impairment of the vestibulo-ocular reflex following the administration of Gentamicin. This will be monitored daily, ideally pre-treatment, during the course of all IV treated patients with ANY dose of Gentamicin and at 7 days following completion of treatment. Recovery of any defecit will be monitored for up to 6 months in patients who show signs of impaired vestibular function.
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Intervention code [1]
285163
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Not applicable
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Comparator / control treatment
No control (observational study)
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
286029
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To detect the incidence of vestibulotoxicity of Gentamicin. This will be done by measuring the VOR velocity gain on the head impulse test with video oculograpy. This involves bedside testing with motion sensing goggles that measure eye velocity and head velocity during head rotation. This test involves the examiner rotating the patients head while they attempt to fixate on a point on the wall. This test takes approximately 3 minutes with 12 minutes of set up. A gain less than that establised in normative data of 0.76 will be regarded as abnormal.
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Assessment method [1]
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Timepoint [1]
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Daily during the course of treatment with Gentamicin, and continuing daily until 1 week after the termination of the course of Gentamicin therapy. Gentamicin toxicity will be measured by a decrease in the VOR gain on the head impulse test with video oculograpy.
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Primary outcome [2]
286123
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To assess the recovery of the VOR gain in affected patients who demonstrate vestibular toxicity up to and including one week post cessation of treatment. Through testing as described above in primary outcome 1.
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Assessment method [2]
286123
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Timepoint [2]
286123
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Weekly - biweekly for one month following the end of the course of Gentamicin, and once monthly subsequently, for up to 6 months or when the VOR shows complete recovery
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Secondary outcome [1]
295019
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Nil
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Assessment method [1]
295019
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Timepoint [1]
295019
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Nil
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Eligibility
Key inclusion criteria
Participants must: be able to give consent prior to or while being treated at Wellington Hospital or Hutt Valley Hospital. The only inclusion criteria at day 1 will be treatment or pending treatment with IV Gentamicin within 24 hrs of measurement of the VOR gain.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients so unwell that they do not wish to have their head moved or who decline testing or who are regarded by the examiner as being too ill to adequately co-operate.
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/07/2012
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
500
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
3977
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New Zealand
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State/province [1]
3977
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Funding & Sponsors
Funding source category [1]
284361
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Hospital
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Name [1]
284361
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Capital and Coast District Health Board (CCDHB)
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Address [1]
284361
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Dr Stuart Mossman
Neurology Department
Clinical Measurement Unit - Level 2
Wellington Hospital
Riddiford Street
Newtown
Wellington 6002
New Zealand
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Country [1]
284361
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New Zealand
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Funding source category [2]
285235
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Hospital
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Name [2]
285235
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Wellington Hospital
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Address [2]
285235
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Wellington Hospital
Riddiford Street
Newtown
Wellington 6002
New Zealand
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Country [2]
285235
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New Zealand
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Primary sponsor type
Hospital
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Name
Capital and Coast District Health Board (CCDHB)
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Address
Wellington Hospital
Riddiford Street
Newtown
Wellington 6002
New Zealand
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Country
New Zealand
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Secondary sponsor category [1]
283301
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None
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Name [1]
283301
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Address [1]
283301
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Country [1]
283301
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
286309
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Multi-Region Ethics Committee
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Ethics committee address [1]
286309
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PO Box 5013
Wellington 6011
New Zealand
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Ethics committee country [1]
286309
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New Zealand
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Date submitted for ethics approval [1]
286309
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12/12/2011
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Approval date [1]
286309
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Ethics approval number [1]
286309
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Summary
Brief summary
Gentamicin can have toxic effects on the inner ear which lessen an individual’s sense of spatial orientation and balance. The aim of this study is to investigate the incidence of this form of toxicity, and to investigate to what extent recovery is possible. This is done by recording eye movements, which have characteristic properties when movement sensors in the inner ear are non-functional.
This study will use video-oculography to enable an objective serial recording of the eye movement abnormality. In selected patients, the eye movements will be recorded over 6 months to observe recovery. This will provide information on how quickly the vestibular-ocular reflex (VOR) function recovers.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
33440
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Address
33440
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Country
33440
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Phone
33440
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Fax
33440
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Email
33440
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Contact person for public queries
Name
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Stuart Mossman
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Address
16687
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Wellington Hospital
Riddiford St
Newtown
Wellington 6002
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Country
16687
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New Zealand
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Phone
16687
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+64 27 873 6086
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Fax
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+64 4 562 8009
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Email
16687
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[email protected]
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Contact person for scientific queries
Name
7615
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Stuart Mossman
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Address
7615
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Department Neurology
Wellington Hospital
Riddiford St
Newtown
Wellington 6002
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Country
7615
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New Zealand
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Phone
7615
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+64278736086
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Fax
7615
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Email
7615
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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