None listed
Conditions
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.
Interventions
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.
Sponsors
Study design
Eligibility
Inclusion criteria
Patients on haemodialysis at Logan Hospital dialysing via an arteriovenous fistulae or an arterovenous graft.
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.