The incidence of hand ischaemia following different techniques for formation of elbow arteriovenous fistula
| ISRCTN | ISRCTN86060133 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86060133 |
| Secondary identifying numbers | N/A |
- Submission date
- 27/01/2010
- Registration date
- 04/05/2010
- Last edited
- 16/11/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Aaron Goh
Scientific
Scientific
Department of Transplant Surgery
Addenbrooke's Hospital
Cambridge
CB2 0QQ
United Kingdom
| aaron.goh@nhs.net |
Study information
| Study design | Prospective randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Randomised controlled trial comparing incidence of hand ischaemia following creation of either conventional brachiocephalic fistula or proximal ulnar/radial-cephalic fistula |
| Study objectives | The risk of developing dialysis access-associated steal syndrome is lower in proximal ulnar/radial-cephalic fistula group than in brachiocephalic fistula group. |
| Ethics approval(s) | Cambridgeshire 1 Research Ethics Committee pending approval as of 28/01/2010 |
| Health condition(s) or problem(s) studied | End stage renal failure for permanent dialysis |
| Intervention | The patients recruited for the trial would be randomised to have either conventional branchiocephalic fistula formation or fistula formation using proximal radial or ulnar artery. The patients suitable for elbow AV fistula would be identified in nephrology clinic and then referred to vascular assess clinic where the patients who are suitable for the trial would be consented. The patients recruited would be randomised to have one of the two techniques of fistula formation. They would be put onto the next available list for fistula formation which would be carried out by experienced transplant specialist registrars or senior clinical fellows. Immediate post-operative outcomes would be recorded. The first follow up would be carried out in vascular assess clinic 2 to 3 weeks after the operation where patients would have digital pressure measurement and would be assessed for presence of symptoms suggesting of fistula-associated hand ischaemia. Further follow up would be carried out at monthly intervals in the first 3 months and then three-monthly thereafter. Patients who develop hand ischaemia symptoms would be assessed immediately by the vascular assess team at Addenbrooke's Hospital either when the patient self present or via referral by their local dialysis unit. The intended follow-up period is up to 12 months. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Presence of dialysis access-associated steal syndrome: 1. Digital pressure measurement 2. Symptoms: cold hand, pain, finger sensibility, strength, cramps 3. Signs: capillary refill time, ulcers, gangrenes 4. Requirement for intervention, surgical revision or ligation Measured at post-operative vascular assess clinic 2 to 3 weeks after the operation or at any timepoint when patients develop ischaemic symptoms up to 12 months follow-up. |
| Secondary outcome measures | 1. Primary (unassisted) patency rate 2. Secondary (assisted) patency rate 3. Complications: haemorrhage, wound infection, stenosis, thrombosis, aneurysm Assessed at follow up clinic at monthly interval for the first 3 months and then 3-monthly thereafter. |
| Overall study start date | 01/06/2010 |
| Completion date | 31/05/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 35 patients each arm (70 patients in total) |
| Key inclusion criteria | 1. Aged 17 to 90 years, either sex 2. Suitable for elbow autogenous arteriovenous (AV) fistula as primary or secondary access for haemodialysis |
| Key exclusion criteria | Patients unable to give consent |
| Date of first enrolment | 01/06/2010 |
| Date of final enrolment | 31/05/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Addenbrooke's Hospital
Cambridge
CB2 0QQ
United Kingdom
CB2 0QQ
United Kingdom
Sponsor information
Cambridge University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research & Development Department
Addenbrooke's Hospital
Cambridge
CB2 0QQ
England
United Kingdom
| Website | http://www.cuh.org.uk/addenbrookes/addenbrookes_index.html |
|---|---|
"ROR" |
https://ror.org/04v54gj93 |
Funders
Funder type
Hospital/treatment centre
Addenbrooke's Hospital (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
16/11/2017: No publications found in PubMed, verifying study status with principal investigator.
