Intradialytic Acid-base Changes and Organic Anion Production With High Versus Low Bicarbonate Hemodialysis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 7
- Locations
- 2
- Primary Endpoint
- Pre-dialysis serum bicarbonate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Arms & Interventions
Low bicarbonate
Low bicarbonate hemodialysis - 30 mEq/L dialysate bicarbonate
Intervention: Low Bicarbonate (Other)
Outcomes
Primary Outcomes
Pre-dialysis serum bicarbonate
Time Frame: 5 weeks
Change in predialysis bicarbonate
Secondary Outcomes
- interleukin-6(5 weeks)
- serum beta-hydroxybutyrate(5 weeks)
- beta-hydroxybutyrate clearance(5 weeks)
- Dialysis symptom questionnaire(5 weeks)
- serum free fatty acids(5 weeks)
- Time to recover from dialysis(5 weeks)
Investigators
Matthew Abramowitz
Assistant Professor
Albert Einstein College of Medicine