Condition category
Urological and Genital Diseases
Date applied
27/01/2010
Date assigned
04/05/2010
Last edited
29/06/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Aaron Goh

ORCID ID

Contact details

Department of Transplant Surgery
Addenbrooke's Hospital
Cambridge
CB2 0QQ
United Kingdom
-
aaron.goh@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Randomised controlled trial comparing incidence of hand ischaemia following creation of either conventional brachiocephalic fistula or proximal ulnar/radial-cephalic fistula

Acronym

Study hypothesis

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

Cambridgeshire 1 Research Ethics Committee pending approval as of 28/01/2010

Study design

Prospective randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/06/2010

Overall trial end date

31/05/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

35 patients each arm (70 patients in total)

Participant exclusion criteria

Patients unable to give consent

Recruitment start date

01/06/2010

Recruitment end date

31/05/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Addenbrooke's Hospital
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust (UK)

Sponsor details

Research & Development Department
Addenbrooke's Hospital
Cambridge
CB2 0QQ
United Kingdom

Sponsor type

Government

Website

http://www.cuh.org.uk/addenbrookes/addenbrookes_index.html

Funders

Funder type

Hospital/treatment centre

Funder name

Addenbrooke's Hospital (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes