Comparison of High Versus Low Bicarbonate Hemodialysis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intradialytic Acid-base Changes and Organic Anion Production With High Versus Low Bicarbonate Hemodialysis

Conditions
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Metabolic Acidosis, Chronic Kidney Disease, End-stage Renal Disease

Intervention / Treatment
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* Other: Low Bicarbonate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low bicarbonate<br>Low bicarbonate hemodialysis - 30 mEq/L dialysate bicarbonate | Other: Low Bicarbonate<br>* Low bicarbonate hemodialysis - 30 mEq/L dialysate bicarbonate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-dialysis serum bicarbonate | Change in predialysis bicarbonate | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum beta-hydroxybutyrate | Change in beta-hydroxybutyrate during dialysis | 5 weeks | 
| beta-hydroxybutyrate clearance | Change in clearance between different dialysates | 5 weeks | 
| interleukin-6 | Change during dialysis | 5 weeks | 
| serum free fatty acids | Change during dialysis | 5 weeks | 
| Time to recover from dialysis | Change between dialysates | 5 weeks | 
| Dialysis symptom questionnaire | Change between dialysates | 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemodialysis, dialysis, acidosis, bicarbonate