Chronic Kidney Disease Clinical Trial
Official title:
Intradialytic Acid-base Changes and Organic Anion Production With High Versus Low Bicarbonate Hemodialysis
NCT number | NCT02098356 |
Other study ID # | 2012-480 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2014 |
Est. completion date | December 2016 |
Verified date | April 2018 |
Source | Albert Einstein College of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 7 |
Est. completion date | December 2016 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Albert Einstein College of Medicine | Bronx | New York |
Lead Sponsor | Collaborator |
---|---|
Albert Einstein College of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pre-dialysis serum bicarbonate | Change in predialysis bicarbonate | 5 weeks | |
Secondary | serum beta-hydroxybutyrate | Change in beta-hydroxybutyrate during dialysis | 5 weeks | |
Secondary | beta-hydroxybutyrate clearance | Change in clearance between different dialysates | 5 weeks | |
Secondary | interleukin-6 | Change during dialysis | 5 weeks | |
Secondary | serum free fatty acids | Change during dialysis | 5 weeks | |
Secondary | Time to recover from dialysis | Change between dialysates | 5 weeks | |
Secondary | Dialysis symptom questionnaire | Change between dialysates | 5 weeks |
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