Effect of Varied Dialysate Bicarbonate Levels on Phosphate and Potassium Removal

NCT ID: NCT01930370

Last Updated: 2015-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2014-12-31

Brief 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

Detailed Description

Elevation of blood phosphate levels in chronic dialysis patients is associated with increased mortality due to cardiovascular events, and if sustained leads to hyperactivity of parathyroid glands and renal bone disease. Similarly, increased calcium-phosphate product as a result of elevated levels of phosphate in the blood is an additional risk factor for vascular calcification. Elevated blood potassium levels is another major electrolyte disorder in patients with advanced renal disease which is potentially life threatening. Therefore control of blood phosphate and potassium levels is a fundamental component of treatment for end stage renal disease. Management of hyperelectrolyte levels in renal failure patients requires restriction of phosphate and potassium intake through dietary measures, promotion of excretion via GI tract through medication delivery (i.e. supplementary binders), and removal through dialysis. All these strategies come with limitations however, specifically adherence to dietary restrictions and medication compliance is poor due to lack of immediate repercussions, as well as the complex kinetics involved with removal via dialysis given the dependence on duration and frequency of dialysis whose manipulation is limited by time considerations for the patient and scheduling issues in the dialysis unit.

Conditions

Chronic Dialysis Patients

Study Design

• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hemodialysis patients

Each patient will be evaluated during a total of 3.5 weeks correlating to routine dialysis treatment appointments. Each participant will start with low bicarbonate, followed by the washout phase (standard bicarbonate), then high bicarbonate, finishing with the follow up period. Dialysis prescription is standardized for each patient throughout the entire 3.5 week study period.

Group Type: EXPERIMENTAL

Bicarbonate hemodialysis solution (low concentration)

Intervention Type: DRUG

One-week experimental session (3 dialysis treatments) with low dialysate bicarbonate (28 mmol/L)

Bicarbonate hemodialysis solution (high concentration)

Intervention Type: DRUG

One-week experimental session with high dialysate bicarbonate (38 mmol/L)

Interventions

Bicarbonate hemodialysis solution (low concentration)

One-week experimental session (3 dialysis treatments) with low dialysate bicarbonate (28 mmol/L)

Intervention Type: DRUG

Bicarbonate hemodialysis solution (high concentration)

One-week experimental session with high dialysate bicarbonate (38 mmol/L)

Intervention Type: DRUG

Eligibility 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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Harvey

Project Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Denis Geary, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

1000014657

Identifier Type: -

Identifier Source: org_study_id