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:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT02484118
Eligibility Criteria:
Inclusion Criteria:
Participants will be selected from the Vancouver Community Dialysis Unit.
The inclusion criteria for participant selection will be:
1. Dialysing for greater than six months to ensure access patency, viability, and stability;
2. Undergoing thrice weekly, four-hour dialysis sessions for uniform dialysis duration;
3. Dialysing with an arteriovenous fistula, either brachio-cephalic or radio-cephalic, to control variances in blood flow rates related to vascular access;
4. Dialysing with 15g needles as organization policy restricts greater flow rates with smaller needle gauge;
5. Dialysing with a dialysate flow (Qd) of 500 mL/min to reduce the possibility of clearance being attributable to differences in Qd;
6. Maintaining transonic vascular access flows of \>600 mL/min for the past 6 months, per Kidney Dialysis Outcomes Quality Initiative (KDOQI) (NKF, 2006) minimum flow guidelines, to ensure access patency.
Exclusion Criteria:
Patients who speak a language other than English, Cantonese, Mandarin, or Punjabi will be excluded due to funding constraints for providing translated informed consent documents. Informed consent documents will only be available in the languages listed above, which are the most common languages spoken/read at the dialysis unit.
Patients who dialyse with a central venous catheter, arteriovenous graft, or femoral arteriovenous fistula will not be invited to participate due to potential confounding from known differences in access flows and vessel quality that may impact clearance values.
Patients who are involved in any other research study that would interfere with their dialysis treatment would be excluded from the study.
Patients who are hemodynamically unstable (e.g.: frequent 'crashing' due to severe hypotension) will be excluded due to the instability this would pose on achieving their prescribed dialysis time (e.g.: if they crash, they may be taken off dialysis early) and resulting data.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT02484118
Study Brief:
Protocol Section:
NCT02484118