Hemodialysis Blood Flow and Urea Clearance

NCT02484118 | Completed

• 1 other identifier: H14-01931
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The study purpose is to determine whether two different hemodialysis blood flow rates each meet national dialysis standards for urea clearance. Urea is used as the primary marker of dialysis adequacy. It is an experimental study with a crossover design of minimum 38 participants. Participants will be selected from the accessible pool of end-stage renal disease clients at the Vancouver Community Dialysis Unit. The participants will dialyse at each pre-determined blood flow rate (320 mL/min and 380 mL/min) for two weeks each. Two forms of urea clearance data will be collected: one value that is routinely calculated by the dialysis machine and recorded on client treatment logs, and another that is calculated in a lab from blood samples.

Conditions

End Stage Renal Failure on Dialysis

Outcome Measures

Primary Outcomes (1)

• Urea clearance

  Two weeks of dialysis at each blood flow rate

Study Arms (2)

Targeted blood flow rate 320 ml/min

EXPERIMENTAL

Hemodialysis blood flow will be targeted at 320 ml/min during hemodialysis for two weeks

Procedure: Hemodialysis blood flow

Targeted blood flow rate 380 ml/min

EXPERIMENTAL

Hemodialysis blood flow will be targeted at 380 ml/min during hemodialysis for two weeks

Procedure: Hemodialysis blood flow

Interventions

Hemodialysis blood flow PROCEDURE

The impact of blood flow rates of 320 ml/m and 380 ml/m will be compared to determine any impact on hemodialysis urea clearance

Targeted blood flow rate 320 ml/min; Targeted blood flow rate 380 ml/min

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants will be selected from the Vancouver Community Dialysis Unit.
• Dialysing for greater than six months to ensure access patency, viability, and stability;
• Undergoing thrice weekly, four-hour dialysis sessions for uniform dialysis duration;
• Dialysing with an arteriovenous fistula, either brachio-cephalic or radio-cephalic, to control variances in blood flow rates related to vascular access;
• Dialysing with 15g needles as organization policy restricts greater flow rates with smaller needle gauge;
• Dialysing with a dialysate flow (Qd) of 500 mL/min to reduce the possibility of clearance being attributable to differences in Qd;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

University of British Columbia, Division of Nephrology

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Study Officials

• John A Duncan, MSc MD FRCPC

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2015
• First Posted: June 29, 2015
• Study Start: May 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: December 9, 2015

Record last verified: 2015-12

Locations

CA (1)