Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000120178
Ethics application status
Approved
Date submitted
20/12/2018
Date registered
25/01/2019
Date last updated
25/01/2019
Date data sharing statement initially provided
25/01/2019
Date results provided
25/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised Placebo controlled trial on Systemic Steroids to protect the Inner ear during Cochlear Implant Surgery
Scientific title
Randomised Placebo controlled trial on Systemic Steroids to protect the Inner ear during Cochlear Implant Surgery
Secondary ID [1] 296922 0
nil known
Universal Trial Number (UTN)
Trial acronym
CIP2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ear health 310874 0
Condition category
Condition code
Ear 309546 309546 0 0
Deafness

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
a slow intravenous injection of Methylprednisolone 13.5mg/kg (1000mg total dose for an average body weight 75Kg) over 10 minutes will be infused through an intravenous cannula 60 minutes prior to surgery.
This procedure will be monitored by the clinical trial coordinator.
Intervention code [1] 313194 0
Treatment: Drugs
Comparator / control treatment
a slow intravenous injection of saline (placebo) will be infused through an intravenous cannula 60 minutes prior to surgery.
Control group
Placebo

Outcomes
Primary outcome [1] 308497 0
Preservation of hearing as assessed by audiometry based on pre and post operative hearing test results.
Timepoint [1] 308497 0
12 months post-surgery
Secondary outcome [1] 365995 0
The effect of the intervention on cochlear implant electrode common ground and monopolar impedances.
Timepoint [1] 365995 0
3 and 12 months after intervention
Secondary outcome [2] 365996 0
Preservation of hearing as assessed by audiometry based on pre and post operative hearing test results.
Timepoint [2] 365996 0
3 months post-intervention

Eligibility
Key inclusion criteria
Aged between 18 & 80 years of age at time of inclusion into the trial
85dB or better pure tone threshold (dBnHL) at 500Hz
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Note medically suitable due to past history of psychosis (mental illness), poorly controlled Type I diabetes, or known adverse reaction to steroids
2. Patients with poorly controlled hypertension, poorly controlled Type II diabetes or active gastro-oesophageal reflux will require medical clearance from the Department of Anaesthesia, or the responsible anaesthetist. Note: such individuals will require medical stabilisation prior to being fit for anaesthesia, so it would be appropriate to determine trial suitability from the anaesthetist when the preoperative medical workup is being undertaken

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Blinding will be achieved by the Pharmacy Department at the RVEEH. Pharmacy department will allocate for patients via a systemic randomised process for each patient who has met essential criteria.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software ( with 50%/50% pick of therapeutic intervention and placebo).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
A 2 proportions test (using 2 binomial proportions) will be computed to compare the proportion of subjects with preserved hearing in the control and treatment groups. Hearing preservation will be defined as a drop in pure tone threshold of equal to 20 dB at 500Hz (i.e. post-operative minus preoperative pure tone thresholds equal to 20 dB). The null hypothesis is that the proportion of hearing preservation will be identical in the two groups of patients. A two-tailed two proportions test with an alpha of 0.05 will determine whether the null hypothesis can be rejected.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
12/04/2011
Date of last participant enrolment
Anticipated
Actual
24/06/2016
Date of last data collection
Anticipated
31/01/2019
Actual
Sample size
Target
108
Accrual to date
Final
108
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12775 0
The Royal Victorian Eye and Ear Hospital - East Melbourne
Recruitment postcode(s) [1] 25236 0
3002 - East Melbourne

Funding & Sponsors
Funding source category [1] 301492 0
Government body
Name [1] 301492 0
National Health Medical Research Council
Country [1] 301492 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
University of Melbourne
Parkville Victoria 3010
Country
Australia
Secondary sponsor category [1] 301505 0
None
Name [1] 301505 0
Address [1] 301505 0
Country [1] 301505 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302236 0
The Royal Victorian Eye and Ear Hospital Human Research and Ethics Committee
Ethics committee address [1] 302236 0
Ethics committee country [1] 302236 0
Australia
Date submitted for ethics approval [1] 302236 0
Approval date [1] 302236 0
22/04/2010
Ethics approval number [1] 302236 0
10/939H

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

Contacts
Principal investigator
Name 89542 0
Prof Stephen O'Leary
Address 89542 0
Dept Surgery - Otolaryngology, University of Melbourne,
5th Floor, Peter Howson Wing
Royal Victoria Eye and Ear Hospital 32 Gisborne Street, East Melbourne Victoria 3001
Country 89542 0
Australia
Phone 89542 0
+613 99298366
Fax 89542 0
Email 89542 0
sjoleary@unimelb.edu.au
Contact person for public queries
Name 89543 0
Thilakavathi Chengodu
Address 89543 0

Thili Chengodu
Dept Surgery - Otolaryngology, University of Melbourne,
5th Floor, Peter Howson Wing
Royal Victoria Eye and Ear Hospital 32 Gisborne Street, East Melbourne Victoria 3001
Country 89543 0
Australia
Phone 89543 0
+61 399298293
Fax 89543 0
Email 89543 0
thili.chengodu@unimelb.edu.au
Contact person for scientific queries
Name 89544 0
Stephen O'Leary
Address 89544 0
Dept Surgery - Otolaryngology, University of Melbourne,
5th Floor, Peter Howson Wing
Royal Victoria Eye and Ear Hospital 32 Gisborne Street, East Melbourne Victoria 3001
Country 89544 0
Australia
Phone 89544 0
+613 99298366
Fax 89544 0
Email 89544 0
sjoleary@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
SourceTitleYear of PublicationDOI
EmbaseSystemic methylprednisolone for hearing preservation during cochlear implant surgery: A double blinded placebo-controlled trial.2021https://dx.doi.org/10.1016/j.heares.2021.108224
N.B. These documents automatically identified may not have been verified by the study sponsor.