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Trial registered on ANZCTR


Registration number
ACTRN12620000341921p
Ethics application status
Not yet submitted
Date submitted
25/02/2020
Date registered
11/03/2020
Date last updated
11/03/2020
Date data sharing statement initially provided
11/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The feasibility of using plastic cannula for haemodialysis treatments
Scientific title
Haemodialysis Plastic Cannulae for patients with end stage kidney disease: A Randomized Crossover Feasibility Study
Secondary ID [1] 300609 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End stage kidney disease 316365 0
Haemodialysis 316366 0
Condition category
Condition code
Renal and Urogenital 314627 314627 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention will be the use of plastic cannulae to facilitate blood access for haemodialysis. Trained registered nurses with a minimum of 1 year experience will be inserting the plastic cannulae. These nurses already are trained in plastic cannulae insertion. Plastic cannulae will be used for a 12 week period, 3 times per week at every haemodialysis session. Participants will be randomized to 12 weeks of plastic cannulae followed by 12 weeks of metal needles (Group 1) or to 12 weeks of metal needles followed by 12 weeks of plastic cannulae (Group 2). There is no washout period as it is not feasible or ethical for patients to not have dialysis treatment (requiring needle or cannula insertion) in between arms. This will take place at renal dialysis units within Barwon Health.

Intervention code [1] 316922 0
Treatment: Devices
Comparator / control treatment
Intervention - Plastic Cannulae
Comparator - Metal Needles

Participants will receive both plastic and metal through a crossover design
Control group
Active

Outcomes
Primary outcome [1] 323008 0
Cannulation success at initial needle insertion. Success is defined by the placement of 2 dialysis needles or cannulae not requiring removal or manipulation.
Timepoint [1] 323008 0
Data will be collected by the renal nurses at the beginning of each haemodialysis session into the electronic medical record (EMR). Data will be dowloaded by the researcher to an excel data sheet at 12 weeks (completion of one arm) and 24 weeks (completion of the other arm).
Primary outcome [2] 323009 0
Needle cannulation complication outcomes. Complications are defined by whether there is bleeding, swelling, bruising, haematoma present after needle insertion and/or requiring more than 2 needles or cannulae in one session. This is assessed by the renal nurse undertaking the cannulation using their normal physical assessment skills.
Timepoint [2] 323009 0
Data will be collected by the renal nurses at the beginning of each haemodialysis session into the electronic medical record (EMR). Data will be dowloaded by the researcher to an excel data sheet at 12 weeks (completion of one arm) and 24 weeks (completion of the other arm).
Secondary outcome [1] 380515 0
Patient anxiety levels at the time of cannulation with either needles or cannulae, as measured by the Patient Health Questionnaire 4.
Timepoint [1] 380515 0
The researcher will distribute the Patient Health Questionnaire 4 to the participating patients at the beginning and end of each arm. E.g. 0 & 12 weeks then 12 and 24 weeks. This data will be analysed and loaded to an excel spreadsheet.

Eligibility
Key inclusion criteria
Diagnosed with end stage kidney disease
Receiving hemodialysis in a Barwon Health clinic.
Receiving dialysis for a minimum of 6 weeks
Using an arterio-venous fistula
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cognitive impairment,
Inability to understand English
Home dialysis patients

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)
After informed consent is obtained, randomization to Group 1 or Group 2
in a 1:1 ratio will be performed via Excel randomization function by an external research
assistant. Allocation concealment will be assured by not providing the randomized sequence
until all participants had been consented. Following randomization, clinician blinding will not
be possible due to the nature of the intervention.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
1:1 ratio will be performed via Excel randomization function by an external research assistant.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Convenience sample. Estimated 20 haemodialysis patients

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15984 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [2] 15985 0
Barwon Health - McKellar Centre campus - North Geelong
Recruitment postcode(s) [1] 29475 0
3220 - Geelong
Recruitment postcode(s) [2] 29476 0
3215 - North Geelong
Recruitment postcode(s) [3] 29477 0
3220 - South Geelong
Recruitment postcode(s) [4] 29478 0
3215 - Geelong North

Funding & Sponsors
Funding source category [1] 305029 0
Charities/Societies/Foundations
Name [1] 305029 0
Kidney Transplant & Diabetes Research Australia
Address [1] 305029 0
1 Port Rd, Adelaide, South Australia 5000
Country [1] 305029 0
Australia
Primary sponsor type
Hospital
Name
Barwon Health
Address
Bellerine St, Geelong VIC 3220
Country
Australia
Secondary sponsor category [1] 305435 0
None
Name [1] 305435 0
Address [1] 305435 0
Country [1] 305435 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 305455 0
Barwon Health Human Research Ethics Committee
Ethics committee address [1] 305455 0
Bellarine Ave, Geelong, Victoria, 3220
Ethics committee country [1] 305455 0
Australia
Date submitted for ethics approval [1] 305455 0
01/04/2020
Approval date [1] 305455 0
Ethics approval number [1] 305455 0

Summary
Brief summary
Patients with kidney disease require 6 metal needles per week. The use of metal dialysis needles can lead to complications such as bruising, swelling and pain. The aim of this study is to measure feasibility related aspects of the introduction of plastic needles in haemodialysis clinics. Participants will receive metal needles and plastic needles and the study will compare needle complications and participant anxiety.
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 100334 0
Ms Vicki Smith
Address 100334 0
Barwon Health Renal Services
74-76 Swanston st
Geelong VIC 3220
Country 100334 0
Australia
Phone 100334 0
+61 3 4215 3609
Fax 100334 0
Email 100334 0
vickis@barwonhealth.org.au
Contact person for public queries
Name 100335 0
Ms Vicki Smith
Address 100335 0
Barwon Health Renal Services
74-76 Swanston st
Geelong VIC 3220
Country 100335 0
Australia
Phone 100335 0
+61 3 4215 3609
Fax 100335 0
Email 100335 0
vickis@barwonhealth.org.au
Contact person for scientific queries
Name 100336 0
Ms Vicki Smith
Address 100336 0
Barwon Health Renal Services
74-76 Swanston st
Geelong VIC 3220
Country 100336 0
Australia
Phone 100336 0
+61 3 4215 3609
Fax 100336 0
Email 100336 0
vickis@barwonhealth.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Feasibility Study
What supporting documents are/will be available?
No other documents available
Summary results
No Results