Comparison of High Versus Low Bicarbonate Hemodialysis

July 1, 2019 updated by: Matthew Abramowitz, Albert Einstein College of Medicine

Intradialytic Acid-base Changes and Organic Anion Production With High Versus Low Bicarbonate Hemodialysis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

7

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
      • Bronx, New York, United States, 10461
        • Albert Einstein College 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

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Low bicarbonate
Low bicarbonate hemodialysis - 30 mEq/L dialysate bicarbonate
Other: Low Bicarbonate
Low bicarbonate hemodialysis - 30 mEq/L dialysate bicarbonate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pre-dialysis serum bicarbonate
Time Frame: 5 weeks
Change in predialysis bicarbonate
5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum beta-hydroxybutyrate
Time Frame: 5 weeks
Change in beta-hydroxybutyrate during dialysis
5 weeks
beta-hydroxybutyrate clearance
Time Frame: 5 weeks
Change in clearance between different dialysates
5 weeks
interleukin-6
Time Frame: 5 weeks
Change during dialysis
5 weeks
serum free fatty acids
Time Frame: 5 weeks
Change during dialysis
5 weeks
Time to recover from dialysis
Time Frame: 5 weeks
Change between dialysates
5 weeks
Dialysis symptom questionnaire
Time Frame: 5 weeks
Change between dialysates
5 weeks

Collaborators and Investigators

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

Sponsor

Albert Einstein College of Medicine

Investigators

  • Principal Investigator: Matthew Abramowitz, MD, MS, Albert Einstein College of Medicine

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

March 1, 2014

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

March 24, 2014

First Submitted That Met QC Criteria

March 25, 2014

First Posted (ESTIMATE)

March 28, 2014

Study Record Updates

Last Update Posted (ACTUAL)

July 5, 2019

Last Update Submitted That Met QC Criteria

July 1, 2019

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-480

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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