A randomized trial comparing standard hemodialysis needling to buttonhole needling: STAN-B study
| ISRCTN | ISRCTN94795553 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94795553 |
| Protocol serial number | N/A |
| Sponsor | University of Calgary (Canada) |
| Funder | University of Calgary |
- Submission date
- 17/05/2006
- Registration date
- 03/07/2006
- Last edited
- 03/04/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jennifer MacRae
Scientific
Scientific
Foothills Hospital
Division of Nephrology
1403 29th Street
North West
Calgary
T2N 2T9
Canada
| Phone | +1 403 944 2745 |
|---|---|
| jennifer.macrae@calgaryhealthregion.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | STAN-B Study |
| Study objectives | Buttonhole needling of patients with an arteriovenous fistula (AVF) will be associated with a decrease in patient-perceived pain compared to standard needling. |
| Ethics approval(s) | Approved by the Conjoint Health Research Ethics Board on 20/04/2006, reference number: E-20037 |
| Health condition(s) or problem(s) studied | Arteriovenous fistula during hemodialysis |
| Intervention | Buttonhole needling versus standard needling |
| Intervention type | Other |
| Primary outcome measure(s) |
Patient-perceived pain |
| Key secondary outcome measure(s) |
1. AVF trauma |
| Completion date | 01/07/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 140 |
| Key inclusion criteria | 1. Chronic hemodialysis patients being treated with dialysis with an AVF 2. An AVF that has been needled consistently for at least four weeks 3. Expected to remain on dialysis for at least two months 4. Aged 18 years or older 5. Able to give informed consent |
| Key exclusion criteria | An active AVF infection |
| Date of first enrolment | 01/07/2006 |
| Date of final enrolment | 01/07/2007 |
Locations
Countries of recruitment
- Canada
Study participating centre
Foothills Hospital
Calgary
T2N 2T9
Canada
T2N 2T9
Canada
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 | 01/10/2012 | Yes | No |