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Altering Bicarbonate Delivery During Hemodialysis to Affect Filtration of Indoxyl Sulfate

NCT ID: NCT02639624

Last Updated: 2017-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-07-01

Brief Summary

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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

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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

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Renal Dialysis Hemodialysis

Keywords

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hemodialysis kidney dialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Low bicarbonate dialysate First

Intervention Type DRUG

Normal bicarbonate dialysate

Intervention Type DRUG

Normal bicarbonate dialysate First

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

Group Type ACTIVE_COMPARATOR

Normal bicarbonate dialysate First

Intervention Type DRUG

Low bicarbonate dialysate

Intervention Type DRUG

Interventions

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Low bicarbonate dialysate First

Intervention Type DRUG

Normal bicarbonate dialysate First

Intervention Type DRUG

Normal bicarbonate dialysate

Intervention Type DRUG

Low bicarbonate dialysate

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jerome Lowenstein

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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14-01343

Identifier Type: -

Identifier Source: org_study_id