This trial is active, not recruiting.

Conditions chronic kidney disease, end-stage renal disease, metabolic acidosis
Treatment low bicarbonate
Phase phase 1
Sponsor Albert Einstein College of Medicine of Yeshiva University
Start date March 2014
End date December 2015
Trial size 20 participants
Trial identifier NCT02098356, 2012-480


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Low bicarbonate hemodialysis - 30 mEq/L dialysate bicarbonate
low bicarbonate
Low bicarbonate hemodialysis - 30 mEq/L dialysate bicarbonate

Primary Outcomes

Pre-dialysis serum bicarbonate
time frame: 5 weeks

Secondary Outcomes

serum beta-hydroxybutyrate
time frame: 5 weeks
beta-hydroxybutyrate clearance
time frame: 5 weeks
time frame: 5 weeks
serum free fatty acids
time frame: 5 weeks
Time to recover from dialysis
time frame: 5 weeks
Dialysis symptom questionnaire
time frame: 5 weeks

Eligibility Criteria

Male or female participants at least 19 years old.

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

Additional Information

Official title Intradialytic Acid-base Changes and Organic Anion Production With High Versus Low Bicarbonate Hemodialysis
Principal investigator Matthew Abramowitz, MD, MS
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Albert Einstein College of Medicine of Yeshiva University.