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Optimizing Access Surgery In Senior hemodialysis patients

Recruiting
Conditions
End-stage renal disease
vascular access
10029149
10003184
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
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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The number of interventions required for each year of hemodialysis treatment</p><br>
Secondary Outcome Measures
NameTimeMethod
<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>
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