Altering Bicarbonate Delivery During Hemodialysis to Affect Filtration of Indoxyl Sulfate

July 27, 2017 updated by: NYU Langone Health
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in pH
Time Frame: 1 Minute, 75 Minutes, 105 Minutes, 180 Minutes, 210 Minutes
1 Minute, 75 Minutes, 105 Minutes, 180 Minutes, 210 Minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Jerome Lowenstein, New York University Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

December 22, 2015

First Submitted That Met QC Criteria

December 22, 2015

First Posted (Estimate)

December 24, 2015

Study Record Updates

Last Update Posted (Actual)

July 31, 2017

Last Update Submitted That Met QC Criteria

July 27, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-01343

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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