Altering Bicarbonate Delivery During Hemodialysis to Affect Filtration of Indoxyl Sulfate

Sponsor

NYU Langone Health (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02639624

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Dialysis Hemodialysis	Drug: Low bicarbonate dialysate First Drug: Normal bicarbonate dialysate First Drug: Normal bicarbonate dialysate Drug: Low bicarbonate dialysate	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Altering Bicarbonate Delivery During Hemodialysis to Affect Filtration of Indoxyl Sulfate

Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Jul 1, 2017

Actual Study Completion Date :

Jul 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Low bicarbonate dialysate First Drug: Normal bicarbonate dialysate
Active Comparator: Normal bicarbonate dialysate First Dialysis with normal (37 mEq) for the first half of dialysis then switched over to low bicarbonate dialysate	Drug: Normal bicarbonate dialysate First Drug: Low bicarbonate dialysate

Arm

Intervention/Treatment

Experimental: 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.

Drug: Low bicarbonate dialysate First

Drug: Normal bicarbonate dialysate

Active Comparator: Normal bicarbonate dialysate First

Dialysis with normal (37 mEq) for the first half of dialysis then switched over to low bicarbonate dialysate

Drug: Normal bicarbonate dialysate First

Drug: Low bicarbonate dialysate

Outcome Measures

Primary Outcome Measures

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

Change in pH [1 Minute, 75 Minutes, 105 Minutes, 180 Minutes, 210 Minutes]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

NYU Langone Health

Investigators

Principal Investigator: Jerome Lowenstein, New York University Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NYU Langone Health

ClinicalTrials.gov Identifier:

NCT02639624

Other Study ID Numbers:

14-01343

First Posted:

Dec 24, 2015

Last Update Posted:

Jul 31, 2017

Last Verified:

Jul 1, 2017

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by NYU Langone Health

hemodialysis

kidney

dialysis

Additional relevant MeSH terms:

Dialysis Solutions

Study Results

No Results Posted as of Jul 31, 2017