Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000937617
Ethics application status
Approved
Date submitted
14/08/2014
Date registered
2/09/2014
Date last updated
28/05/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of plastic fistula cannulae versus metal fistula needles in haemodialysis in-centre patients
Scientific title
Comparison of plastic fistula cannulae versus metal fistula needles in haemodialysis incentre patients in terms of number of cannulation failures, intra-dialytic infiltrations and needlestick injuries along with staff and patient satisfaction.
Secondary ID [1] 285166 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End Stage Renal Failure 292757 0
Condition category
Condition code
Renal and Urogenital 293047 293047 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The trial duration is four, one month treatment blocks. Each treatment block will be comprised of a one month period using either metal or plastic cannulisation devices. The double crossover design should allow for any bias attributable to unfamiliarity with the test needles. The design will also allow us to assess for any learner effect with using the new plastic cannulae. Subjects will be randomly allocated to one of four treatment sequences, so that we can assess for treatment order effect.

Each patient will use both devices equally over the four month period. They will be randomised into four different arms of the trial consisting of four different regimens. The four different regimens will be one month blocks consisting of the use of the devices for every dialysis session during that month as followed;

1) Plastic, Metal, Plastic, Metal
2) Metal, Plastic, Plastic, Metal
3) Plastic, Metal, Metal, Plastic
4) Metal, Plastic, Metal, Plastic

There will be no washout period but the crossover design is to minimise bias as much as possible. Each patient will have the device they are required to be using for the month in adherance to the trial protocol, clearly labelled on their care path.
Intervention code [1] 290018 0
Treatment: Devices
Comparator / control treatment
Plastic cannulae compared to the normal metal fistula needles.
Control group
Active

Outcomes
Primary outcome [1] 292919 0
Failed cannulations

Failed Cannulation is defined as the necessity to use second device in order to access the fistula. This will be recorded on the data collection tool.
Timepoint [1] 292919 0
Accessing dialysis fistula or graft every schedualed haemodialysis therapy using the same device each month over four months.
Primary outcome [2] 292983 0
Intra-dialytic blows or dislogements. These will be recorded on the data collection tool if and when they occur.
Timepoint [2] 292983 0
Each month over the four month trial for each device any intra-dialytic blows or dislogements will be recorded on the data collection tool.
Secondary outcome [1] 309933 0
Staff satisfaction survey designed specifically for the study.
Timepoint [1] 309933 0
Staff satisfaction survey will be administerd monthly over the four months of the trial.
Secondary outcome [2] 310074 0
Patient satisfaction survey designed specifically for the study.
Timepoint [2] 310074 0
Patient satisfaction survey will be administered monthly over the four months of the trial.
Secondary outcome [3] 310075 0
Needle stick injuries.
Timepoint [3] 310075 0
Data will be collected at each haemodialysis session over the four month trial period.

Eligibility
Key inclusion criteria
Patients on haemodialysis at Logan Hospital dialysing via an arteriovenous fistulae or an arterovenous graft.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients not willing to consent, patients unable to consent due to cognitive decline or unstable mental illness, patients less than 18 years of age, patients who are highly self-caring and insert their own needles.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2014
Actual
28/10/2014
Date of last participant enrolment
Anticipated
14/11/2014
Actual
5/11/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 2856 0
Logan Hospital - Meadowbrook

Funding & Sponsors
Funding source category [1] 289781 0
Self funded/Unfunded
Name [1] 289781 0
Country [1] 289781 0
Primary sponsor type
Hospital
Name
Logan Hospital
Address
Logan Hospital
Cnr Armstrong and Loganlea Rd
MEADOWBROOK Qld 4131
Country
Australia
Secondary sponsor category [1] 288471 0
None
Name [1] 288471 0
Address [1] 288471 0
Country [1] 288471 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291512 0
Metro South HREC
Ethics committee address [1] 291512 0
Centres for Health Research
Level 7 Translational Research Institute
37 Kent Street
Woolloongabba Qld 4102
Ethics committee country [1] 291512 0
Australia
Date submitted for ethics approval [1] 291512 0
01/07/2014
Approval date [1] 291512 0
05/08/2014
Ethics approval number [1] 291512 0
HREC/14/QPAH/323

Summary
Brief summary
Comparison of plastic cannulae and metal fistula needles. The different outcomes associated with the use of plastic fistula cannulae compared with metal fistula needles will be investigated in haemodialysis in-centre patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50682 0
Dr Ken-Soon Tan
Address 50682 0
Renal Dialysis Unit
Logan Hospital
P.O. Box 4096
Loganholme Qld 4129
Country 50682 0
Australia
Phone 50682 0
+61 7 3299 8987
Fax 50682 0
Email 50682 0
ken-soon.tan@health.qld.gov.au
Contact person for public queries
Name 50683 0
Ms Karin Ahearn
Address 50683 0
Renal Dialysis Unit
Logan Hospital
P.O. Box 4096
Loganholme Qld 4129
Country 50683 0
Australia
Phone 50683 0
+61 7 3299 8987
Fax 50683 0
Email 50683 0
karin.ahearn@health.qld.gov.au
Contact person for scientific queries
Name 50684 0
Dr Ken-Soon Tan
Address 50684 0
Renal Dialysis Unit
Logan Hospital
P.O. Box 4096
Loganholme Qld 4129
Country 50684 0
Australia
Phone 50684 0
+61 7 3299 8987
Fax 50684 0
Email 50684 0
ken-soon.tan@health.qld.gov.au

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
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