Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-24 @ 11:52 PM
NCT ID:
NCT05911451
Eligibility Criteria:
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 (the Dusseux risk score was adapted for patients between 65 and 70 years by assigning -3 points to this age category)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT05911451
Study Brief:
Protocol Section:
NCT05911451