NCT01930370

Effect of Varied Dialysate Bicarbonate Levels on Phosphate and Potassium Removal

Effect of Varied Dialysate Bicarbonate Levels on Phosphate and Potassium Removal: A Pilot Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Bicarbonate hemodialysis solution (low concentration)	One-week experimental session (3 dialysis treatments) with low dialysate bicarbonate (28 mmol/L)
DRUG	Bicarbonate hemodialysis solution (high concentration)	One-week experimental session with high dialysate bicarbonate (38 mmol/L)

Timeline

• Start date: 2010-03-01
• Primary completion: 2014-07-01
• Completion: 2014-12-01
• First posted: 2013-08-28
• Last updated: 2015-05-28

Locations

1 site across 1 country: Canada