Optimizing Access Surgery In Senior Hemodialysis Patients (NCT05911451) | Clinical Trial Compass
CompletedNot Applicable
Optimizing Access Surgery In Senior Hemodialysis Patients
Netherlands166 participantsStarted 2019-11-01
Plain-language summary
The number of elderly hemodialysis patients is growing. Vascular access complications are a major determinant of the quality of life and health care costs for these vulnerable patients. The three different types of vascular access, i.e. autologous arteriovenous fistulas, arteriovenous grafts, and central venous catheters, have never been compared in randomized controlled trials. This project will deliver the much-needed evidence to determine the optimal strategy for vascular access creation in elderly hemodialysis patients in order to deliver better health care at lower costs.
Who can participate
Age range65 Years
SexALL
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Inclusion criteria
✓. Adult patients aged 65 years or older
✓. End-stage renal disease with unlikely recovery of kidney function according to the attending nephrologist
✓. Hemodialysis is the intended long-term modality of treatment for end-stage renal disease
✓. Fit for vascular access surgery as determined by the local multidisciplinary vascular access team 5a. Expected to start hemodialysis treatment within 6 months at the time of treatment assignment; or 5b. Treated with hemodialysis for 6 months or less at the time of treatment assignment using a tunneled or non-tunneled central venous catheter for vascular access
Exclusion criteria
✕. Patent arteriovenous fistula or graft already in place
✕. Prior unsuccessful arteriovenous fistula or graft vascular access surgery
✕. Kidney transplantation planned within 6 months
✕. Metastatic malignancies or other condition associated with a life expectancy of \<6 months, in the opinion of the attending nephrologist
What they're measuring
1
Access-related intervention rate
Timeframe: Variable follow-up time of at least 1 year
✕. Dusseux risk score \<5, indicating an usually long life expectancy for elderly patients starting hemodialysis treatment (the Dusseux risk score was adapted for patients between 65 and 70 years by assigning -3 points to this age category)