To compare surgical strategies for vascular access creation in elderly hemodialysis patients.
ID
Source
Brief title
Condition
- Nephropathies
- Vascular therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The number of interventions required for each year of hemodialysis treatment
Secondary outcome
Patient-reported outcome measures (SF-12 / DSI / SF-VAQ)
Health care costs
Access-related complications
Days in hospital
Mortality
Background 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. In this project, we 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.
Study objective
To compare surgical strategies for vascular access creation in elderly
hemodialysis patients.
Study design
Parallel group, multicenter randomized controlled trial.
Intervention
Subjects will be randomized into three study groups with a different surgical
strategy for the creation of a vascular access for hemodialysis:
1. Autologous arteriovenous fistula creation (recommended by current guidelines)
2. Arteriovenous graft implantation
3. Central venous catheter placement
Study burden and risks
Burden: filling out the questionnaires will take 5 hours and can be done with
the aid of nurses during dialysis treatments.
Risks:
There are three types of vascular access for hemodialysis: autologous
arteriovenous fistulas, arteriovenous grafts, and central venous catheters.
Each type of vascular access has its own advantages and disadvantages.
Autologous arteriovenous fistulas have the least long-term complications, but
maturation into a functional access takes time and often does not succeed.
Arteriovenous grafts can be used early but more often experience stenosis and
thrombosis. Central venous catheters can be used immediately and are placed
with a minimally invasive procedure, but are associated with increased risk of
serious infections and mortality in observational studies. Participation in
this trial exposes the subject to the risks (as well as the benefits) of the
allocated type of vascular access.
P. Debyeplein 25
Maastricht 6202AZ
NL
P. Debyeplein 25
Maastricht 6202AZ
NL
Listed location countries
Age
Inclusion criteria
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.
Exclusion criteria
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL70385.068.19 |