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Altering Bicarbonate Delivery During Hemodialysis to Affect Filtration of Indoxyl Sulfate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02639624
Recruitment Status : Withdrawn (07/27/2017 Unable to contact research team to confirm reason for withdrawing study.)
First Posted : December 24, 2015
Last Update Posted : July 31, 2017
Sponsor:
Information provided by (Responsible Party):
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.

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : January 2016
Actual Primary Completion Date : July 1, 2017
Actual Study Completion Date : July 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Change in pH [ Time Frame: 1 Minute, 75 Minutes, 105 Minutes, 180 Minutes, 210 Minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639624


Locations
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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Jerome Lowenstein New York University Medical School
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02639624    
Other Study ID Numbers: 14-01343
First Posted: December 24, 2015    Key Record Dates
Last Update Posted: July 31, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NYU Langone Health:
hemodialysis
kidney
dialysis
Additional relevant MeSH terms:
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Dialysis Solutions
Pharmaceutical Solutions