Optimizing Access Surgery In Senior hemodialysis patients
- Conditions
- End-stage renal diseasehemodialysisvascular access
- Registration Number
- NL-OMON28751
- Lead Sponsor
- Academisch Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 195
1. Adult patients aged 70 years or older;
2. End-stage renal disease with unlikely recovery of kidney function according to the at-tending nephrologist;
3. Hemodialysis is the intended long-term modality of treatment for end-stage renal dis-ease;
4. Fit for vascular access surgery as determined by the local multidisciplinary vascular access team;
5. A. Expected to start hemodialysis treatment within 6 months at the time of treatment assignment; or
B. 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;
6. Planning to remain in one of participating dialysis centers for at least 1 year;
7. Suitable vascular anatomy for all types of vascular access based on duplex ultrasound of the arms, defined as:
• at least one suitable configuration for an arteriovenous fistula using minimal arterial and venous diameters of 2mm for radiocephalic fistulas and 3mm for brachiocephalic and brachiobasilic fistulas;
• at least one suitable configuration for an arteriovenous graft using minimal arterial and venous diameters of 3mm and 4mm, respectively; and
• at least one open internal jugular vein for a central venous catheter.
1. Patent arteriovenous fistula or graft already in place;
2. Prior unsuccessful arteriovenous fistula or graft vascular access surgery;
3. Kidney transplantation planned within 6 months;
4. Metastatic malignancies or other condition associated with a life expectancy of <6 months, in the opinion of the attending nephrologist;
5. Unable to provide informed consent;
6. Dusseux risk score <5, indicating an unusually long life expectancy for elderly patients starting hemodialysis treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The number of access-related interventions required for each person-year of hemodialysis treatment
- Secondary Outcome Measures
Name Time Method Patient-reported outcome measures (SF-12 / DSI measured every 3 months and SF-VAQ measured every month until the latest of one year of follow-up or one year of dialysis treatment has been reached), health care costs, access-related complications, days in hospital, and mortality