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Altering Bicarbonate Delivery During Hemodialysis to Affect Filtration of Indoxyl Sulfate

Altering Bicarbonate Delivery During Hemodialysis to Affect Filtration of Indoxyl Sulfate

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02639624
Enrollment
0
Registered
2015-12-24
Start date
2016-01-31
Completion date
2017-07-01
Last updated
2017-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodialysis, Renal Dialysis

Keywords

hemodialysis, kidney, dialysis

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.

Interventions

DRUGLow bicarbonate dialysate First
DRUGNormal bicarbonate dialysate First
DRUGNormal bicarbonate dialysate
DRUGLow bicarbonate dialysate

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in the amount of Indoxyl Sulfate level in the first half of dialysis as compared to controls1 Minute, 75 Minutes, 105 Minutes, 180 Minutes, 210 Minutes

Secondary

MeasureTime frame
Change in pH1 Minute, 75 Minutes, 105 Minutes, 180 Minutes, 210 Minutes

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026