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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
Scientific title
Prospective detection of vestibular abnormalities resulting from the administration of Gentamicin and documentation of their subsequent recovery.
Secondary ID [1] 273522 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gentamicin vestibulotoxicity 279260 0
Sepsis treated with Gentamicin 286458 0
Condition category
Condition code
Ear 279467 279467 0 0
Other ear disorders
Neurological 285563 285563 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 285163 0
Not applicable
Comparator / control treatment
No control (observational study)
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286029 0
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.
Timepoint [1] 286029 0
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.
Primary outcome [2] 286123 0
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.
Timepoint [2] 286123 0
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
Secondary outcome [1] 295019 0
Nil
Timepoint [1] 295019 0
Nil

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment outside Australia
Country [1] 3977 0
New Zealand
State/province [1] 3977 0

Funding & Sponsors
Funding source category [1] 284361 0
Hospital
Name [1] 284361 0
Capital and Coast District Health Board (CCDHB)
Country [1] 284361 0
New Zealand
Funding source category [2] 285235 0
Hospital
Name [2] 285235 0
Wellington Hospital
Country [2] 285235 0
New Zealand
Primary sponsor type
Hospital
Name
Capital and Coast District Health Board (CCDHB)
Address
Wellington Hospital
Riddiford Street
Newtown
Wellington 6002
New Zealand
Country
New Zealand
Secondary sponsor category [1] 283301 0
None
Name [1] 283301 0
Address [1] 283301 0
Country [1] 283301 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286309 0
Multi-Region Ethics Committee
Ethics committee address [1] 286309 0
Ethics committee country [1] 286309 0
New Zealand
Date submitted for ethics approval [1] 286309 0
12/12/2011
Approval date [1] 286309 0
Ethics approval number [1] 286309 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33440 0
Address 33440 0
Country 33440 0
Phone 33440 0
Fax 33440 0
Email 33440 0
Contact person for public queries
Name 16687 0
Stuart Mossman
Address 16687 0
Wellington Hospital
Riddiford St
Newtown
Wellington 6002
Country 16687 0
New Zealand
Phone 16687 0
+64 27 873 6086
Fax 16687 0
+64 4 562 8009
Email 16687 0
[email protected]
Contact person for scientific queries
Name 7615 0
Stuart Mossman
Address 7615 0
Department Neurology
Wellington Hospital
Riddiford St
Newtown
Wellington 6002
Country 7615 0
New Zealand
Phone 7615 0
+64278736086
Fax 7615 0
Email 7615 0
[email protected]

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
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Documents added automatically
No additional documents have been identified.