End-stage renal failure Urological and Genital Diseases Chronic kidney disease, stage 5
Conditions
Interventions
Participants will be randomized during the screening visit using a central randomization facility accessed online via an interactive web-based randomization system (IWRS) hosted by the Robertson Centr
Sponsors
NHS Greater Glasgow and Clyde
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age =18 years at the time of informed consent 2. Capable of complying with Protocol requirements, including follow-up 3. Incident patient with end-stage renal failure (ESRF) 4. The time of estimated renal replacement therapy (RRT) or haemodialysis is anticipated within the subsequent 6 months, or have already started within the previous 21 days prior to recruitment (urgent vascular access to provide life-sustaining haemodialysis will not be an exclusion) 5. Sufficiently fit to withstand initial surgery and maintenance procedures 6. Have contemporary vein and arterial mapping with ultrasound (US) 7. No scheduled immediate transplant within the next 60 days 8. No previous vascular access procedures other than central venous catheter for urgent haemodialysis of duration 5 mm 9.2.2. Length of vein for cannulation 65 years 9.3.2. Diabetes mellitus 9.3.3. BMI >29 kg/m² 9.3.4. Other patient factors e.g. preservation of a dominant arm and poor vessels in the non-dominant 10. Suitable anatomy for placement of an ecAVG (Gore Acuseal), not necessarily in the same limb
Exclusion criteria
Exclusion criteria: 1. Been treated in a drug study within 60 days of study enrollment 2. Pregnant at the time of consent 3. Life expectancy 3 weeks 7. Vessels not suitable for an AVG (advised minimum size 4.5 mm inflow brachial artery, 3 mm radial artery, 3 mm vein – complete details in SOP) 8. A good option for an AVF (>50% likelihood of success) in a suitable upper limb that includes all anatomical favorable measurements and characteristics: wrist – radial artery >3 mm AND cephalic vein >3 mm AND cephalic vein length >6 cm AND less than 5 mm from skin surface; elbow – brachial artery >4 mm AND cephalic vein >4 mm AND cephalic vein length greater than 6 cm AND less than 5 mm from skin surface. These are not absolute and should be taken in the context of a clinical decision. 9. A history or evidence of severe systemic disease including: 9.1. Cardiac disease (NYHA Functional Class III or IV, evidenced by the inability to lie flat), myocardial infarction in the 6 weeks prior to randomisation, ventricular tachyarrhythmia requiring continuing treatment, unstable angina 9.2. Systolic blood pressure 15,000 cells/mm³) other than treated CVC use 10. Known or suspected central vein stenosis/occlusion on the side of planned access 11. History of heparin-induced thrombocytopenia 12. Biological immunosuppression 13. Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the Acuseal / fistula e.g. poor compliance 14. Unwilling or unable to attend standard 3-monthly surveillance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to vascular access abandonment as measured by the time from procedure to loss of patency of vascular access. This will be measured at 6 weeks post procedure (visit 3) and thereafter 3 monthly at month 3, month 9, month 12, month 15, month 18, month 21 and month 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cost of patient care in each arm will be analysed by a health economist. Healthcare resource use data will be collected by electronic case report form (eCRF) from the trial and supplemented from external routine sources, including Hospital Episode Statistics (England) and equivalent databases for other UK nations where feasible. This will be classified into intervention-related resource use (e.g. medical consumables and medicines utilised, the time required to perform the procedure, intervention medical team composition including relevant NHS bands, length of stay etc.) and access-related/follow-up resource use (e.g. access-related complications and hospitalisations, re-interventions, creation of alternative access, GP/nurse/Allied Health Professional/outpatient visits, ambulance attendance, A&E attendance, inpatient admissions, critical care stay). Adverse events related to the intervention that result in resource utilisation will also be recorded and included in the analysis. This will be calculated for the duration the patient is in the trial. 2. Quality of life will be measured by VAS-QoL and EQ-5D. EQ-5D only will be assessed at visit 1 screening and visit 2 procedure. EQ-5D and VAS-QoL will be assessed at Visit 3 Post Operative visit and 3 monthly during visits 4-11. 3. Primary-assisted patency, defined as the interval from the time of access placement until access thrombosis, or the time of measurement of patency, measured by the medical opinion of the staff attempting to use the vascular access for dialysis treatment. This will be measured once access has been established for the duration the patient is in the trial. 4. Functional (secondary) patency, defined as the interval from the time of access placement until access abandonment, thrombosis, or the time of measurement of patency including preceding successful interventional or surgical procedures to maintain or re-establish patency. This will be measured | — |
Countries
England, Greece, Italy, Scotland, Spain, United Kingdom, Wales
Contacts
Public ContactClare Dolan
Outcome results
None listed