Overview

Effect of Varied Dialysate Bicarbonate Levels on Phosphate and Potassium Removal

Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
0
Participant gender:
All
Summary
Modeling of bicarbonate within the dialysate fluid, specifically a lower than standard concentration has been suggested in facilitating the removal of phosphate and potassium. To test this hypothesis, the study will use a cross-over study design to evaluate phosphate and potassium removal during dialysis by altering bicarbonate concentration in dialysis fluid (i.e. high bicarbonate, standard bicarbonate washout, low bicarbonate), and compare the effects of the different dialysate bicarbonate concentrations on the removal of phosphate and potassium during hemodialysis
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The Hospital for Sick Children
Treatments:
Dialysis Solutions
Hemodialysis Solutions
Pharmaceutical Solutions
Criteria
Inclusion Criteria:

- Patients 0-18 years old

- Patients receiving maintenance hemodialysis* for a total of 9-15 hours per week

- Pre-dialysis serum potassium value between 4.0 and 6.5 mmol/L on the first day of the
treatment protocol

- Pre-dialysis serum phosphate value greater than low normal for age on the first day of
the treatment protocol

- Pre-dialysis serum bicarbonate (total CO2) value between 18 and 30 mmol/L on the first
day of the treatment protocol

- Pre-dialysis corrected calcium value between 1.80-2.85 mmol/L on the first day of the
treatment protocol

Exclusion Criteria:

- Hemodynamically unstable patients (requiring inotropes or midodrine for support).

- Pre-dialysis potassium value < 4.0 or > 6.5 mmol/L on the first day of the treatment
protocol

- Pre-dialysis serum phosphate value less than low normal for age on the first day of
the treatment protocol (i.e. hypophosphatemia)

- Pre-dialysis serum bicarbonate (total CO2) value <18 or > 30 mmol/L on the first day
of the treatment protocol

- Pre-dialysis corrected calcium <1.8 and >2.85 mmol/L on the first day of the treatment
protocol

- Patients mechanically ventilated

- Drugs that could modify internal phosphate and potassium balance such as insulin,
bicarbonate injection, hypertonic dextrose solution or mannitol infusion during HD