NCT02639624

Altering Bicarbonate Delivery During Hemodialysis to Affect Filtration of Indoxyl Sulfate

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Dialysis
• Hemodialysis

Interventions

Type	Name	Description
DRUG	Low bicarbonate dialysate First
DRUG	Normal bicarbonate dialysate First
DRUG	Normal bicarbonate dialysate
DRUG	Low bicarbonate dialysate

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2015-12-24
• Last updated: 2017-07-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study