Chronic Kidney Disease, End-stage Renal Disease, Metabolic Acidosis
Conditions
Keywords
hemodialysis, dialysis, acidosis, bicarbonate
Brief summary
This study will compare hemodialysis treatment with a standard, high-bicarbonate dialysis bath versus a lower bicarbonate dialysis bath, and will compare intradialytic acid-base changes and overall control of metabolic acidosis with the 2 treatment regimens.
Detailed description
This study will compare hemodialysis treatment with a standard, high-bicarbonate dialysis bath versus a lower bicarbonate dialysis bath, and will compare intradialytic acid-base changes and overall control of metabolic acidosis with the 2 treatment regimens. These parameters will be assessed in patients currently receiving high-bicarbonate hemodialysis as part of usual care. They will then be switched to a lower bicarbonate prescription, after which these parameters will be reassessed. The study will also examine changes in inflammatory markers, glycemic control, ketogenesis, and lipolysis.
Interventions
OTHERLow Bicarbonate
Low bicarbonate hemodialysis - 30 mEq/L dialysate bicarbonate
Sponsors
Albert Einstein College of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 * Receiving chronic thrice-weekly conventional hemodialysis for at least 6 months
Exclusion criteria
* Use of oral alkali within the previous month * Hospitalization within the previous month * Inability to provide written informed consent * Plans for kidney transplant in the next 2 months * Planned change in phosphate binder therapy within the next month * Pregnancy, or planned pregnancy in the next 2 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pre-dialysis serum bicarbonate | 5 weeks | Change in predialysis bicarbonate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| beta-hydroxybutyrate clearance | 5 weeks | Change in clearance between different dialysates |
| interleukin-6 | 5 weeks | Change during dialysis |
| serum beta-hydroxybutyrate | 5 weeks | Change in beta-hydroxybutyrate during dialysis |
| Time to recover from dialysis | 5 weeks | Change between dialysates |
| Dialysis symptom questionnaire | 5 weeks | Change between dialysates |
| serum free fatty acids | 5 weeks | Change during dialysis |
Countries
United States
Outcome results
None listed