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.
Brief Title
Comparison of High Versus Low Bicarbonate Hemodialysis
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.
Completion Date
Completion Date Type
Actual
Conditions
Chronic Kidney Disease
End-stage Renal Disease
Metabolic Acidosis
Eligibility Criteria
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
* 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
Inclusion Criteria
Inclusion Criteria:
* Age \>18
* Receiving chronic thrice-weekly conventional hemodialysis for at least 6 months
* Age \>18
* Receiving chronic thrice-weekly conventional hemodialysis for at least 6 months
Gender
All
Gender Based
false
Keywords
hemodialysis
dialysis
acidosis
bicarbonate
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
19 Years
NCT Id
NCT02098356
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2012-480
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Intradialytic Acid-base Changes and Organic Anion Production With High Versus Low Bicarbonate Hemodialysis
Primary Outcomes
Outcome Description
Change in predialysis bicarbonate
Outcome Measure
Pre-dialysis serum bicarbonate
Outcome Time Frame
5 weeks
Secondary Outcomes
Outcome Description
Change in beta-hydroxybutyrate during dialysis
Outcome Time Frame
5 weeks
Outcome Measure
serum beta-hydroxybutyrate
Outcome Description
Change in clearance between different dialysates
Outcome Time Frame
5 weeks
Outcome Measure
beta-hydroxybutyrate clearance
Outcome Description
Change during dialysis
Outcome Time Frame
5 weeks
Outcome Measure
interleukin-6
Outcome Description
Change during dialysis
Outcome Time Frame
5 weeks
Outcome Measure
serum free fatty acids
Outcome Description
Change between dialysates
Outcome Time Frame
5 weeks
Outcome Measure
Time to recover from dialysis
Outcome Description
Change between dialysates
Outcome Time Frame
5 weeks
Outcome Measure
Dialysis symptom questionnaire
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
19
Investigators
Investigator Type
Principal Investigator
Investigator Name
Matthew Abramowitz
Investigator Email
matthew.abramowitz@einsteinmed.org
Investigator Phone