End stage renal disease requiring urgent vascular access for haemodialysis Urological and Genital Diseases Chronic kidney disease, stage 5
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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.
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of culture proven bacteraemia at 6 months (per 1,000 dialysis days) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom