Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000949482p
Ethics application status
Submitted, not yet approved
Date submitted
30/05/2016
Date registered
19/07/2016
Date last updated
19/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Is prophylactic Potassium Citrate effective in preventing bladder stones after acute spinal cord injury?
Scientific title
The effect of Potassium Citrate in preventing bladder stones after acute spinal cord injury
Secondary ID [1] 289338 0
none
Universal Trial Number (UTN)
U1111-1183-4448
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
GU stones in SCI 298952 0
spinal cord injury 298954 0
bladder stones
 299371 0
Condition category
Condition code
Neurological 299025 299025 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 299026 299026 0 0
Other physical medicine / rehabilitation
Renal and Urogenital 299356 299356 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Potassium Citrate 30-60 mEq orally daily. This equates to 5ml twice daily orally.
Duration of intervention - 3 months
Intervention code [1] 294898 0
Prevention
Comparator / control treatment
control group will not receive any intervention
Control group
Active

Outcomes
Primary outcome [1] 298488 0
presence of bladder stones on Xray, flexible cystoscopy or ultrasound
Timepoint [1] 298488 0
3 months post intervention commencement (end of acute admission phase)
Secondary outcome [1] 324351 0
nil
Timepoint [1] 324351 0
nil

Eligibility
Key inclusion criteria
persons with acute spinal cord injury
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
congenital, pre-existing chronic spinal cord injury

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)
allocation not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like coin-tossing and dice-rolling
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/08/2016
Actual
Date of last participant enrolment
Anticipated
1/09/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment outside Australia
Country [1] 7928 0
New Zealand
State/province [1] 7928 0
Burwood catchment area (South of Taupo)

Funding & Sponsors
Funding source category [1] 293714 0
Hospital
Name [1] 293714 0
Canterbury District Health Board
Country [1] 293714 0
New Zealand
Primary sponsor type
Hospital
Name
Canterbury District Health Board (CDHB)
Address
Burwood Spinal Unit, Burwood Hospital, Burwood Road, Christchurch 8083, New Zealand
Country
New Zealand
Secondary sponsor category [1] 292547 0
None
Name [1] 292547 0
none
Address [1] 292547 0
n/a
Country [1] 292547 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 295147 0
Health and Disability Ethics Committee New Zealand
Ethics committee address [1] 295147 0
Ministry of Health
Ethics Department
Freyberg Building
Reception – Ground Floor
20 Aitken Street
Wellington 6011
Ethics committee country [1] 295147 0
New Zealand
Date submitted for ethics approval [1] 295147 0
24/05/2016
Approval date [1] 295147 0
Ethics approval number [1] 295147 0

Summary
Brief summary
To investigate whether early intervention with Potassium citrate can reduce incidence of renal and bladder calculi following acute spinal cord injury
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66302 0
Dr Peter Aspell
Address 66302 0
Burwood Spinal Unit,
Burwood Hospital,
Burwood Road,
Christchurch 8083
Country 66302 0
New Zealand
Phone 66302 0
+64211144193
Fax 66302 0
Email 66302 0
peter.aspell@cdhb.health.nz
Contact person for public queries
Name 66303 0
Peter Aspell
Address 66303 0
Burwood Spinal Unit,
Burwood Hospital,
Burwood Road,
Christchurch 8083
Country 66303 0
New Zealand
Phone 66303 0
+64211144193
Fax 66303 0
Email 66303 0
peter.aspell@cdhb.health.nz
Contact person for scientific queries
Name 66304 0
Peter Aspell
Address 66304 0
Burwood Spinal Unit,
Burwood Hospital,
Burwood Road,
Christchurch 8083
Country 66304 0
New Zealand
Phone 66304 0
+64211144193
Fax 66304 0
Email 66304 0
peter.aspell@cdhb.health.nz

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.