Comparison of High Versus Low Bicarbonate Hemodialysis

Not Applicable

Completed

• Conditions: End-stage Renal Disease; Metabolic Acidosis; Chronic Kidney Disease
• Interventions: Other: Low Bicarbonate

• Registration Number: NCT02098356
• Lead Sponsor: Albert Einstein College of Medicine

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 Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-24
• Study First Submitted QC: 2014-03-25
• Study First Posted: 2014-03-28
• Primary Completion: 2015-12
• Study Completion: 2016-12
• Status Verified: 2018-04
• Last Update Submitted: 2019-07-01
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low bicarbonate	Low Bicarbonate	Low bicarbonate hemodialysis - 30 mEq/L dialysate bicarbonate

Primary Outcome Measures

Name	Time	Method
Pre-dialysis serum bicarbonate	5 weeks	Change in predialysis bicarbonate

Secondary Outcome Measures

Name	Time	Method
beta-hydroxybutyrate clearance	5 weeks	Change in clearance between different dialysates
serum beta-hydroxybutyrate	5 weeks	Change in beta-hydroxybutyrate during dialysis
serum free fatty acids	5 weeks	Change during dialysis
Time to recover from dialysis	5 weeks	Change between dialysates
Dialysis symptom questionnaire	5 weeks	Change between dialysates
interleukin-6	5 weeks	Change during dialysis

Trial Locations

Locations (1)

Albert Einstein College of Medicine; 🇺🇸 Bronx, New York, United States