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Trial registered on ANZCTR
Registration number
ACTRN12613000895785
Ethics application status
Approved
Date submitted
8/08/2013
Date registered
12/08/2013
Date last updated
12/08/2013
Type of registration
Prospectively registered
Titles & IDs
Public title
A pilot study to investigate the effects of one week of treatment with acetazolamide on the arterial levels of carbon dioxide in patients receiving non-invasive ventilation for the treatment of obesity hypoventilation syndrome
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Scientific title
A pilot study to investigate the effects of one week of treatment with acetazolamide on the arterial levels of carbon dioxide in patients receiving non-invasive ventilation for the treatment of obesity hypoventilation syndrome
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Secondary ID [1]
282903
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nil known
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Universal Trial Number (UTN)
U1111-1144-1469
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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:
Obesity hypoventilation syndrome
289717
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Condition category
Condition code
Respiratory
290043
290043
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0
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Other respiratory disorders / diseases
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Diet and Nutrition
290183
290183
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0
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Obesity
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Intervention will consist of treatment with oral acetazolamide tablets at a dose of 250mg twice a day for a period of one week. Compliance will be assessed by tablet count at the end of the week.
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Intervention code [1]
287602
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Treatment: Drugs
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Comparator / control treatment
This is a pilot study and does not contain a control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
290095
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Level of arterial carbon dioxide (from arterial blood gas specimen mmHg)
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Assessment method [1]
290095
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Timepoint [1]
290095
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one week and again at one month
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Secondary outcome [1]
303928
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ventilatory response to hypercapnia (slope of graph of minute ventilation against end tidal CO2)
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Assessment method [1]
303928
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Timepoint [1]
303928
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at one week and again at one month
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Eligibility
Key inclusion criteria
Diagnosis of obesity hypoventilation syndrome
Currently receiving non-invasive ventilation in s-mode
No hospitalisation with decompensation of respiratory failure for at least 3 months
Willing and able to give informed consent
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Minimum age
18
Years
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Maximum age
99
Years
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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
Unable to provide informed consent
Poor renal function (eGFR <30ml/min)
Poor compliance with non-invasive ventilation (average usage less than 4 hours per night)
Allergy or previous adverse reaction to sulphur drugs
Use of supplemental oxygen
Any other safety concern at investigators discression
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All participants will receive the treatment in this pilot study
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will not occur
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
Paired t-test for values before and after treatment
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
15/08/2013
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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
10
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
5250
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New Zealand
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State/province [1]
5250
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Funding & Sponsors
Funding source category [1]
287690
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University
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Name [1]
287690
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University of otago, Wellington
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Address [1]
287690
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University of Otago, Wellington
P.O.Box 7342
Wellington South
Wellington 6242
New Zealand
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Country [1]
287690
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New Zealand
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Primary sponsor type
University
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Name
University of Otago, Wellington
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Address
University of Otago, Wellington
P.O.Box 7342
Wellington South
Wellington 6242
New Zealand
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Country
New Zealand
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Secondary sponsor category [1]
286423
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None
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Name [1]
286423
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none
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Address [1]
286423
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none
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Country [1]
286423
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289651
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Central health and Disability Ethics Committee
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Ethics committee address [1]
289651
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1 The terrace
P.O. Box 5013
Wellington
6011
New Zealand
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Ethics committee country [1]
289651
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New Zealand
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Date submitted for ethics approval [1]
289651
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Approval date [1]
289651
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29/07/2013
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Ethics approval number [1]
289651
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13/CEN/105
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Summary
Brief summary
This study aims to investigate whether adding a medicine in pill form to the non-invasive ventilation that you are already receiving can make that non-invasive ventilation more successful.
This study aims to see whether adding acetazolamide to treatment with non-invasive ventilation can improve daytime hypercapnia by improving ventilatory response to hypercapnia. It will take subjects with a diagnosis of obesity hypoventilation syndrome who are already receiving treatment with non-invasive ventilation, but who still have abnormally high carbon dioxide levels despite that treatment.
They will have initial baseline measurements including arterial blood gas on air, renal function blood test and measurement of ventilatory response to hypercapnia. Providing their renal function is good enough they will then take acetazolamide at a dose of 250mg twice a day for one week. They will continue to use non-invasive ventilation at night throughout the study as normal. They will return at the end of that week for repeat arterial blood gas and ventilatory response to hypercapnia testing to see whether the acetazolamide has brought about any change. Further arterial blood gas and ventilatory response to hypercapnia testing will occur after one month to see whether any changes caused have persisted in the absence of the trial drug but with continued use of non-invasive ventilation.
This is a pilot study aiming to ensure the tolerability of this treatment and to quantify the magnitude of any changes seen. It would act to help inform a power calculation for a larger study should it be shown to be beneficial.
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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
41738
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A/Prof Alister Neill
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Address
41738
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University of Otago Wellington
P.O Box 7342
Wellington South
Wellington
6242
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Country
41738
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New Zealand
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Phone
41738
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+64 043855999 ext 5618
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Fax
41738
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Email
41738
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[email protected]
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Contact person for public queries
Name
41739
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Dr James Pickering
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Address
41739
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Clinical Measurement Unit
Wellington Hospital
Private Bag 7902
Wellington
6242
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Country
41739
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New Zealand
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Phone
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+64 04 3855999
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Fax
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Email
41739
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[email protected]
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Contact person for scientific queries
Name
41740
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Dr James Pickering
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Address
41740
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Clinical Measurement Unit
Wellington Hospital
Private Bag 7902
Wellington
6242
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Country
41740
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New Zealand
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Phone
41740
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+64 04 3855999 bleep 2430
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Fax
41740
0
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Email
41740
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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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