Condition category
Surgery
Date applied
16/10/2020
Date assigned
27/10/2020
Last edited
27/10/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Many patients with kidney failure need dialysis to remove toxins from the bloodstream. During dialysis, blood from the patient is taken into the dialysis machine, cleaned and then returned back to the patient. This requires entry and exit ‘access’ points into patients’ blood vessels. The best form of access is called a fistula (an artificial connection between the artery and vein made with a small operation in the arm).

Unfortunately, fistula creation is not an exact science. Up to half fail within a year of being created. The reason why fistulas fail and how this can be prevented are largely unknown.

The fistula operation can be performed under local anaesthetic (i.e. injection of anaesthetic into the wrist or elbow to numb the area where the surgeon will operate) or anaesthetic ‘block’ (i.e. injection of anaesthetic around the nerves in the neck or armpit to numb the entire arm for many hours). It is known that the ‘block’ also improves blood flow to the arm. Theoretically, this could improve the success of a fistula operation but this is not yet clear. Currently, in the UK there is no agreement on what to do and each unit chooses based on local preference and resources.

This study aims to compare the success of fistulas created under local anaesthetic versus an anaesthetic ‘block’.

Who can participate?
Adult patients with either end-stage renal disease (ESRD) and receiving renal replacement therapy (RRT), or chronic kidney disease (CKD) stage IV or V and referred for arteriovenous fistula creation.

What does the study involve?
Patients requiring fistula creation will be randomised (like tossing a coin) to have their fistula made under local anaesthetic or ‘block’. After the surgery most patients will be able to go home on the same day. They will be reviewed twice afterwards (3 and 12 months following surgery) to assess how they, and their fistula, are getting on.

Recent research has shown that patients consider fistula function rather than simply blood flow is most important when determining the success of a procedure. Therefore success will be judged if a fistula can deliver dialysis without the need for any additional procedures or surgery. This will be easy to assess in patients receiving dialysis. However, it is anticipated that about half of study participants will not have started dialysis yet. In these patients the fistula will be assessed by ultrasound (jelly scan) instead. The trial team will compare the number of patients with a successful fistula at 12 months in each group to determine which anaesthetic technique (if either) is better.

Information will be collected about complications (infections, blockages, needling problems), additional procedures, hospital visits or ‘lines’ (plastic tubes inserted to allow dialysis if the fistula isn’t working properly). Finally, patients will be asked to complete some short questionnaires to evaluate general wellbeing. One of the questionnaires has been recently designed by doctors specifically to look at the effect of the ‘access’ on patient lifestyle. This information will allow us to determine if the treatments are good value for money.

What are the possible benefits and risks of participating?
Wherever possible, patients will be followed-up in their dialysis units to avoid additional hospital visits and only hospitals that already offer both local anaesthetic and ‘block’ within their current practice will be eligible to participate. In this way, it is hoped that the costs of running the trial will be kept down and the trial team will draw on existing relationships to make everything run efficiently.

It is anticipated that the results of this trial will be used to influence the decision-making of NHS funders and ensure that, in the future, the best treatment option is available for every patient with kidney failure in the UK.

Where is the study run from?
NHS Greater Glasgow and Clyde (UK)

When is the study starting and how long is it expected to run for?
From October 2020 to May 2024

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Emma Aitken
emmaaitken@nhs.net

Trial website

Contact information

Type

Scientific

Primary contact

Dr Emma Aitken

ORCID ID

http://orcid.org/0000-0001-8939-7478

Contact details

Department of Renal Surgery
Queen Elizabeth University Hospital
Glasgow
G51 4TF
United Kingdom
+44 (0)141 452 6209
emmaaitken@nhs.net

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRAS 290482

Study information

Scientific title

Anaesthesia Choice for Creation of arteriovenous fistulae (ACCess)

Acronym

ACCess

Study hypothesis

Does regional (RA) compared to local anaesthesia (LA) improve unassisted functional patency at 1 year and/or cost-effectiveness in patients undergoing primary radiocephalic (RCF) or brachiocephalic (BCF) fistula creation?

Ethics approval

Pending

Study design

Multicentre observer-blinded randomized controlled trial (RCT) with an internal pilot and embedded process evaluation study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Participant information sheets are currently in draft and being prepared for ethics submission, will be added once approved

Condition

Patients undergoing primary (Radiocephalic fistula) RCF or (Brachiocephalic fistula) creation

Intervention

Each participant will be randomised, at a ratio of 1:1, to either receive Regional Anaesthesia (RA) or Local Anaesthesia (LA) during their planned surgery to create a connection between an artery and a vein. (Primary radio- (RCF) or brachio-cephalic (BCF) fistula surgery).

Those randomised to the RA Intervention Arm will receive a 1:1 mixture of 0.5% L-bupivacaine, 1% lidocaine and epinephrine (mixed to 1 in 400,000 final concentration). Maximum dose limits are dependent on weight of participants - 2 mg/kg for bupivacaine and 7 mg/kg for lidocaine with epinephrine. This is administered by single Perineural injection.

Those randomised to the LA Comparator Arm will receive a 1:1 mixture of 0.5% L-bupivacaine and 1% lidocaine. Maximum dose limits are dependent on weight of participants - 2 mg/kg for bupivacaine and 3mg/kg for lidocaine will be observed. This is administered by single subcutaneous injection.

Intervention type

Drug

Phase

Not Applicable

Drug names

1. Regional anaesthesia (RA): an ultrasound-guided supraclavicular or axillary block 1:1 mixture of 0.5% L-bupivacaine and 1% lidocaine with epinephrine (final concentration 1 in 400,000)
2. Local anaesthesia (LA): a 1:1 mixture of 0.5% L-bupivacaine and 1% lidocaine

Primary outcome measure

1. Unassisted functional arteriovenous fistula (AVF) patency at 1 year measured as the ability of access to uninterruptedly deliver the prescribed dialysis without intervention at 12 months

Secondary outcome measures

1. Vascular access complications (e.g. infection, stenosis, steal, thrombosis, bleeding) measured at 3 and 12 months
2. Re-operation/re-intervention measured using the number of re-operations/re-interventions at 3 and 12 months
3. Alternative accesses measured using alternative access requirements at 3 and 12 months
4. Cannulation difficulties measured using access complications (inc infection, stenosis, thrombosis, steal, bleeding) at 3 and 12 months
5. Mortality measured using the number of deaths at 3 and 12 months
6. Dialysis and access modality measured using change of renal replacement therapy at 3 and 12 months
7. Access-related hospitalisation measured using a number of re-operation/re-intervention required to maintain or re-establish patency (revisional surgery, angioplasty, stenting or thrombectomy) at 3 and 12 months
8. Health-related quality of life (HR-QoL) measured using patient-reported questionnaires at 3 and 12 months
9. Cost-effectiveness measured at 3 and 12 months
10. Efficacy and safety of anaesthesia measured using perioperative pain score on a numeric rating scale (NRS 0-10) and collection of relevant adverse events at 3 and 12 months

Overall trial start date

01/10/2020

Overall trial end date

31/05/2024

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged >18 years
2. End-stage renal disease (ESRD) and receiving renal replacement therapy (RRT), or chronic kidney disease (CKD) stage IV or V and referred for primary radiocephalic (RCF) or brachiocephalic (BCF) fistula creation

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

566

Participant exclusion criteria

1. Unable or unwilling to provide informed consent
2. Preference for general or alternative anaesthesia
3. Active infection at surgical or anaesthetic site
4. Previous ipsilateral arteriovenous fistula (AVF) creation (a previous attempt at distal AVF creation which fails immediately is not considered a contraindication, however any distal access which has previously run sufficiently to mature the outflow vein or proximal revision of an existing AVF is considered a contraindication)
5. Known ipsilateral cephalic arch or central venous stenosis (even if previously treated)
6. USS evidence of stenosis in inflow artery
7. Radial or brachial artery <1.8 mm diameter and/or cephalic vein <2 mm at wrist or <3 mm at elbow (with tourniquet) on pre-operative USS
8. Allergy to Local anaesthesia (LA) or any excipient agents
9. Acquired or inherited coagulopathy (including warfarin/ heparin/ novel oral anticoagulant use where it has not been possible to stop the anticoagulation in anticipation of surgery) and/or platelets <75 or INR >1.4
10. Significant pre-existing neurological disorder affecting the upper limb
11. Weight <45 kg

Recruitment start date

01/05/2021

Recruitment end date

30/05/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queen Elizabeth University Hospital
1345 Govan Road Govan
Glasgow
G51 4TF
United Kingdom

Trial participating centre

Stobhill Ambulatory Care Hospital
133 Balornock Rd
Glasgow
G21 3UW
United Kingdom

Trial participating centre

Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Trial participating centre

Belfast City Hospital
Lisburn Road
Belfast
BT9 7AB
United Kingdom

Trial participating centre

Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

Trial participating centre

Dumfries and Galloway Royal Infirmary
A75 Cargenbridge
Dumfires
DG2 8RX
United Kingdom

Trial participating centre

The Freeman Hospital
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom

Trial participating centre

Guy's and St Thomas' NHS Foundation Trust
Westminster Bridge Road
London
SE1 7EH
United Kingdom

Trial participating centre

The James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Trial participating centre

University Hospital Monklands
Monkscourt Ave
Airdrie
ML6 0JS
United Kingdom

Trial participating centre

University Hospital Hairmyres
218 Eaglesham Road East Kilbride
Glasgow
G75 8RG
United Kingdom

Trial participating centre

Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom

Trial participating centre

Ninewells Hospital
James Arnott Dr
Dundee
DD2 1SG
United Kingdom

Trial participating centre

Norfolk and Norwich University Hospital
Colney Lane
Norwich
NR4 7UY
United Kingdom

Trial participating centre

The Royal Free Hospital
Pond St Hampstead
London
NW3 2QG
United Kingdom

Trial participating centre

Royal Sussex Hospital
Barry Building Eastern Rd
Brighton
BN2 5BE
United Kingdom

Sponsor information

Organisation

NHS Greater Glasgow and Clyde

Sponsor details

Grahamston Road
Paisley
PA2 7DE
United Kingdom
+44 (0)141 314 4012
Maureen.Travers@ggc.scot.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.nhsggc.org.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned Publication in a high-impact peer-reviewed journal within one year after the end of trial.

IPD sharing statement:
The trial statisticians, health economist, and TSC will have access to the full dataset. Site investigators will be able to access the full dataset if a formal request describing their plans is made to the steering group.

The trial protocol, full trial report, anonymised participant level dataset, and statistical code for generating the results will be made publically available within 12 months of the End of Trial via an online data repository and by direct request from the CI

Data is being collected via eCRF hosted by the Robertson Centre for Biostatistics at Glasgow University. Anonymised data entered into the eCRF will be managed and stored by the RCB in line with the detailed Data Management Plan, which will be developed for the study in line with approved templates, reviewed regularly, and all members of the project team will adhere to the plan, and well established local SOPs. All anonymised trial data will be retained for 10 years following End of Trial Glasgow CTU (of which RCB is part) will serve as custodian of the data generated from this trial.

Intention to publish date

31/05/2025

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

16/10/2020: Trial’s existence confirmed by National Institute for Health Research (NIHR).