Altering Bicarbonate Delivery During Hemodialysis to Affect Filtration of Indoxyl Sulfate

Not Applicable

Withdrawn

• Conditions: Renal Dialysis; Hemodialysis
• Interventions: Drug: Low bicarbonate dialysate First; Drug: Normal bicarbonate dialysate First; Drug: Normal bicarbonate dialysate; Drug: Low bicarbonate dialysate

• Registration Number: NCT02639624
• Lead Sponsor: NYU Langone Health

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-12-22
• Study First Submitted QC: 2015-12-22
• Study First Posted: 2015-12-24
• Study Start: 2016-01
• Status Verified: 2017-07
• Primary Completion: 2017-07-01
• Study Completion: 2017-07-01
• Last Update Submitted: 2017-07-27
• Last Update Posted: 2017-07-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Chronic Stable Dialysis for at least 6 months

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Low bicarbonate dialysate First	Low bicarbonate dialysate First	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.
Low bicarbonate dialysate First	Normal bicarbonate dialysate	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.
Normal bicarbonate dialysate First	Normal bicarbonate dialysate First	Dialysis with normal (37 mEq) for the first half of dialysis then switched over to low bicarbonate dialysate
Normal bicarbonate dialysate First	Low bicarbonate dialysate	Dialysis with normal (37 mEq) for the first half of dialysis then switched over to low bicarbonate dialysate

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change in pH	1 Minute, 75 Minutes, 105 Minutes, 180 Minutes, 210 Minutes

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States