Arteriovenous fistula cannulation in haemodialysis patients
| ISRCTN | ISRCTN27841616 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27841616 |
| Protocol serial number | 4967 |
| Sponsor | Royal Berkshire and Battle Hospitals NHS Trust (UK) |
| Funder | Nipro Europe NV - UK Branch (UK) |
- Submission date
- 29/04/2010
- Registration date
- 29/04/2010
- Last edited
- 22/07/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
London Road
Reading
RG1 5AN
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised interventional treatment trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomised interventional treatment study to determine best practise of arteriovenous fistula cannulation in haemodialysis patients |
| Study objectives | A randomised controlled trial to assess the best practice needling of the arterio-venous (AV) fistula between buttonhole method and rotating needling sites. |
| Ethics approval(s) | Berkshire Research Ethics Committee approved on the 19th March 2007 (ref: 07/Q1602/1) |
| Health condition(s) or problem(s) studied | Topic: Renal and Urogenital; Subtopic: Renal and Urogenital (all Subtopics); Disease: Renal |
| Intervention | Buttonhole method of cannulation using blunt needles versus normal rotating sites practice with sharp needles. Follow up length: 12 months Study entry: single Randomisation only |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
The study has been designed to determine the primary and secondary AVF patency rates at 1 year and the complication rate for each cannulation method. |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 16/06/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target sample size at registration | 140 |
| Key inclusion criteria | Any male/female participants (no age limits) receiving hamodialysis via AV fistula who are willing to participate |
| Key exclusion criteria | Unable or unwilling to give informed consent |
| Date of first enrolment | 22/10/2007 |
| Date of final enrolment | 16/06/2009 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
RG1 5AN
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2013 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |