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Optimizing Access Surgery In Senior hemodialysis patients

Recruiting
Conditions
End-stage renal disease
hemodialysis
vascular 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
Inclusion Criteria

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.

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 unusually long life expectancy for elderly patients starting hemodialysis treatment

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The number of access-related interventions required for each person-year of hemodialysis treatment
Secondary Outcome Measures
NameTimeMethod
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
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