Comparison of High Versus Low Bicarbonate Hemodialysis

NCT ID: NCT02098356

Last Updated: 2019-07-05

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

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-12-31

Brief Summary

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This study will compare hemodialysis treatment with a standard, high-bicarbonate dialysis bath versus a lower bicarbonate dialysis bath, and will compare intradialytic acid-base changes and overall control of metabolic acidosis with the 2 treatment regimens.

Detailed Description

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This study will compare hemodialysis treatment with a standard, high-bicarbonate dialysis bath versus a lower bicarbonate dialysis bath, and will compare intradialytic acid-base changes and overall control of metabolic acidosis with the 2 treatment regimens. These parameters will be assessed in patients currently receiving high-bicarbonate hemodialysis as part of usual care. They will then be switched to a lower bicarbonate prescription, after which these parameters will be reassessed. The study will also examine changes in inflammatory markers, glycemic control, ketogenesis, and lipolysis.

Conditions

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Chronic Kidney Disease End-stage Renal Disease Metabolic Acidosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low bicarbonate

Low bicarbonate hemodialysis - 30 mEq/L dialysate bicarbonate

Group Type EXPERIMENTAL

Low Bicarbonate

Intervention Type OTHER

Low bicarbonate hemodialysis - 30 mEq/L dialysate bicarbonate

Interventions

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Low Bicarbonate

Low bicarbonate hemodialysis - 30 mEq/L dialysate bicarbonate

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age \>18
* Receiving chronic thrice-weekly conventional hemodialysis for at least 6 months

Exclusion Criteria

* Use of oral alkali within the previous month
* Hospitalization within the previous month
* Inability to provide written informed consent
* Plans for kidney transplant in the next 2 months
* Planned change in phosphate binder therapy within the next month
* Pregnancy, or planned pregnancy in the next 2 months
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Albert Einstein College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Matthew Abramowitz

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matthew Abramowitz, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Locations

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Albert Einstein College of Medicine

The Bronx, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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2012-480

Identifier Type: -

Identifier Source: org_study_id

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