Optimizing Access Surgery In Senior hemodialysis patients
- Conditions
- End-stage renal diseasevascular access1002914910003184
- Registration Number
- NL-OMON54598
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 195
1. Adult patients aged 65 years or older
2. End-stage renal disease with unlikely recovery of kidney function according
to the attending nephrologist
3. Hemodialysis is the intended long-term modality of treatment for end-stage
renal disease
4. 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
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 usually long life expectancy for
elderly patients starting hemodialysis treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The number of interventions required for each year of hemodialysis treatment</p><br>
- Secondary Outcome Measures
Name Time Method <p>Patient-reported outcome measures (SF-12 / DSI / SF-VAQ)<br /><br>Health care costs<br /><br>Access-related complications<br /><br>Days in hospital<br /><br>Mortality</p><br>