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Optimizing Access Surgery In Senior hemodialysis patients

Optimizing Access Surgery In Senior hemodialysis patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28751
Enrollment
195
Registered
2019-08-04
Start date
2019-12-17
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-stage renal disease

Interventions

1. Arteriovenous graft implantation 2. Central venous catheter placement 3. Autologous arteriovenous fistula creation (recommended by current guidelines)

Sponsors

Academisch Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
The number of access-related interventions required for each person-year of hemodialysis treatment

Secondary

MeasureTime frame
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

Contacts

Public ContactMaarten Snoeijs

Maastricht UMC+

maarten.snoeijs@mumc.nl0031625097694

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)