Condition category
Urological and Genital Diseases
Date applied
15/05/2014
Date assigned
27/05/2014
Last edited
22/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Patients with end-stage kidney failure need dialysis to remove harmful waste (toxins) from the blood. Haemodialysis is the most common, well known, type of dialysis and is chosen by 90% of patients in the West of Scotland. In haemodialysis, the blood is removed from the patients' body though a vein and the toxins removed by a dialysis machine before being returned. Most people need three sessions a week, with each session lasting approximately 3 to 4 hours. In order to allow haemodialysis, there first needs to be access to one of the patients blood vessels (vascular access). This involves creating an arteriovenous fistula (AVF). This is a surgically modified blood vessel created by connecting an artery to a vein and it allows needles to be inserted into the arm for haemodialysis. Unfortunately, a AVF cannot be used immediately after it has been created. It needs to be left to 'mature' for 6-8 weeks before it can be used. Not every patient can wait 6-8 weeks before dialysis begins - possibly because their kidney failure has presented at a late stage or because of delays in performing the procedure. The recent National Kidney Care Vascular Access Report indicates that 30-35% of patients are referred for AVF less than 90 days prior to the date when they need to start dialysis, leaving insufficient time for planning, surgery and maturation. At the moment, only 40% of patients in the UK start haemodialysis via an AVF. The majority of the others start haemodialysis via a tunnelled central venous catheter (TCVC). TCVCs are plastic lines which are inserted into patients' necks to achieve quick vascular access for haemodialysis. This is far from ideal, however, and steps are taken to insure that this procedure is used as little as possible due to the significantly greater risk of infection and 3 fold increase in mortality rate when compared with using an AVF. One potential alternative to TCVCs is 'immediate access' arteriovenous grafts (AVGs). AVGs provide an intermediate option between an AVF and TCVC. It is a tube of prosthetic material which is inserted into the patients' arm/ leg and joined onto their own blood vessels in a operation. Haemodialysis can be performed within 24 hours of the operation and the risks of infections and other complications are much lower than those of TCVCs. Preliminary work has shown that AVGs are acceptable, practicable and cost-effective alternatives to TCVCs in patients requiring urgent vascular access for haemodialysis. We now propose to test this hypothesis in a randomised trial comparing TCVCs to 'immediate access' AVGs.

Who can participate?
Adult patients aged 18 or over with end stage kidney failure who need urgent vascular access for haemodialysis.

What does the study involve?
Patients will be randomly allocated into one of two groups. One group will receive the AVGs and the other TCVC. They will be followed up and monitored for complications for 6 months.

What are the possible benefits and risks of participating?
Patients receiving the AVG are anticipated to be at lower risk of infection. However, it is a surgical procedure which, in itself, does involve some risk (risks associated with anaesthetic, bleeding and steal syndrome).

Where is the study run from?
Department of Renal Surgery, Western Infirmary, Glasgow, UK

When is study starting and how long is it expected to run for?
1st January 2014. Recruitment is anticipated to take ~ 1 year.

Who is funding the study?
W.L. Gore Associates, UK

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

Trial website

Contact information

Type

Scientific

Primary contact

Ms Emma Aitken

ORCID ID

Contact details

Clinical Research Fellow
Department of Renal Surgery
Western Infirmary
Dumbarton Road
Glasgow
G116NY
United Kingdom
-
emmaaitken@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

13/WS/0087

Study information

Scientific title

A randomised controlled trial of immediate Access Arteriovenous Grafts (AVGs) vs Tunnelled Central Venous Catheters (TCVCs)

Acronym

AVG vs TCVC

Study hypothesis

Early cannulation AVGs+/-AVFs will reduce the rate of culture proven bacteraemia and other complications compared to TCVC.

Ethics approval

West of Scotland Research Ethics Committee; 16/08/2013; 13/WS/0087

Study design

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 disease requiring urgent vascular access for haemodialysis

Intervention

Early cannulation arteriovenous graft (AVG) (Acuseal) vs. tunnelled central venous catheter

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Rate of culture proven bacteraemia at 6 months (per 1,000 dialysis days)

Secondary outcome measures

1. Culture proven bacteremia rates at 1 year and 2 years
2. Primary, secondary and functional patency rates at 3 months, 6 months, 1 and 2 years
3. Stenosis/ thrombosis/ re-intervention rates (including need for urokinase infusions and TCVC replacement)
4. Cost-effectiveness
5. Quality of life
6. Mortality and cardiovascular morbidity at 1 year and 2 years
7. Efficiency and efficacy of dialysis [urea reduction ratio (URR), Kt/V, Qa and recirculation)
8. Delays to treatment and the impact on service provision
9. Readmission rates
10. Other adverse events

Overall trial start date

01/01/2014

Overall trial end date

01/01/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. All adult patients 18 years or older with end stage renal disease requiring urgent access to permit haemodialysis.
2. Both patients new to dialysis and those with long-term TCVCs who require new access for haemodialysis will be eligible for inclusion in the study.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

118

Participant exclusion criteria

1. Significant cardiorespiratory co-morbidities
2. Significant systemic sepsis
3. Women who are pregnant or breast feeding
4. Lack of capacity or inability to provide informed consent
5. Declines participation in the study
6. Claustrophobia or severe back pain (MRI end-points only)

Recruitment start date

01/01/2014

Recruitment end date

01/01/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Western Infirmary
Glasgow
G116NY
United Kingdom

Sponsor information

Organisation

NHS Greater Glasgow and Clyde (UK)

Sponsor details

c/o Dr Maureen Travers
Research and Development Office
Western infirmary
Tennent Building
1st Floor
38 Church Street
Glasgow
G116NY
United Kingdom
-
maureen.travers@ggc.scot.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

W.L.Gore & Associates (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

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25885054

Publication citations

Additional files

Editorial Notes