Altering Bicarbonate Delivery During Hemodialysis to Affect Filtration of Indoxyl Sulfate

Study Overview
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Brief Summary
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This is a non randomized crossover trial investigating whether changing the pattern of bicarbonate administration during hemodialysis will result in the more efficient filtration of highly protein bound solutes. The experimental group will be dialyzed with low bicarbonate dialysate for the first half of dialysis then switched over to normal bicarbonate dialysate for the second half. The control group will be dialyzed entirely with normal bicarbonate dialysate. The two groups will switch one week late and patients will serve as their own matched controls for a completely standard dialysis and one that is split into two halves with different bicarbonate concentrations.

Detailed Description
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Investigators will try to perform dialysis with a low bicarbonate bath which will leave patients blood pH (Hydrogen ion concentration) relatively unchanged then switch to a normal bicarbonate bath during the second half of dialysis so that they attain the pH (Hydrogen ion concentration) they normally would. Investigators will use these measurements to test test the hypothesis that Indoxyl Sulfate (IS) binds to proteins with greater affinity under basic conditions and further to test the hypothesis that it is possible to remove a greater amount of Indoxyl Sulfate (IS) when patients are maintained relatively acidotic during dialysis for a longer period of time due to the greater availability of free IS that can pass through the dialyzer.

Official Title
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Altering Bicarbonate Delivery During Hemodialysis to Affect Filtration of Indoxyl Sulfate

Conditions
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Renal Dialysis, Hemodialysis

Intervention / Treatment
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* Drug: Low bicarbonate dialysate First
* Drug: Normal bicarbonate dialysate First
* Drug: Normal bicarbonate dialysate
* Drug: Low bicarbonate dialysate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic Stable Dialysis for at least 6 months Exclusion Criteria: Patients with serum potassium concentration below 4.0 mEq/L on previous monthly lab test or corrected serum calcium below 8.5 mEq/L Hospitalization within the past 12 months Adults unable to consent Children Pregnant women Prisoners

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low bicarbonate dialysate First<br>Dialysis with low bicarbonate dialysate (expected normal for an adult  24 mEq) for the first half of dialysis then switched over to normal bicarbonate dialysate for the second half. | Drug: Low bicarbonate dialysate First<br> <br> Drug: Normal bicarbonate dialysate<br> <br> |
| Active Comparator: Normal bicarbonate dialysate First<br>Dialysis with normal (37 mEq) for the first half of dialysis then switched over to low bicarbonate dialysate | Drug: Normal bicarbonate dialysate First<br> <br> Drug: Low bicarbonate dialysate<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the amount of Indoxyl Sulfate level in the first half of dialysis as compared to controls |  | 1 Minute, 75 Minutes, 105 Minutes, 180 Minutes, 210 Minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pH |  | 1 Minute, 75 Minutes, 105 Minutes, 180 Minutes, 210 Minutes | 

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