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Comparison of High Versus Low Bicarbonate Hemodialysis

Primary Purpose

Chronic Kidney Disease, End-stage Renal Disease, Metabolic Acidosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low Bicarbonate
Sponsored by
Albert Einstein College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring hemodialysis, dialysis, acidosis, bicarbonate

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Albert Einstein College of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Low bicarbonate

Arm Description

Low bicarbonate hemodialysis - 30 mEq/L dialysate bicarbonate

Outcomes

Primary Outcome Measures

Pre-dialysis serum bicarbonate
Change in predialysis bicarbonate

Secondary Outcome Measures

serum beta-hydroxybutyrate
Change in beta-hydroxybutyrate during dialysis
beta-hydroxybutyrate clearance
Change in clearance between different dialysates
interleukin-6
Change during dialysis
serum free fatty acids
Change during dialysis
Time to recover from dialysis
Change between dialysates
Dialysis symptom questionnaire
Change between dialysates

Full Information

First Posted
March 24, 2014
Last Updated
July 1, 2019
Sponsor
Albert Einstein College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02098356
Brief Title
Comparison of High Versus Low Bicarbonate Hemodialysis
Official Title
Intradialytic Acid-base Changes and Organic Anion Production With High Versus Low Bicarbonate Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albert Einstein College of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, End-stage Renal Disease, Metabolic Acidosis
Keywords
hemodialysis, dialysis, acidosis, bicarbonate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low bicarbonate
Arm Type
Experimental
Arm Description
Low bicarbonate hemodialysis - 30 mEq/L dialysate bicarbonate
Intervention Type
Other
Intervention Name(s)
Low Bicarbonate
Intervention Description
Low bicarbonate hemodialysis - 30 mEq/L dialysate bicarbonate
Primary Outcome Measure Information:
Title
Pre-dialysis serum bicarbonate
Description
Change in predialysis bicarbonate
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
serum beta-hydroxybutyrate
Description
Change in beta-hydroxybutyrate during dialysis
Time Frame
5 weeks
Title
beta-hydroxybutyrate clearance
Description
Change in clearance between different dialysates
Time Frame
5 weeks
Title
interleukin-6
Description
Change during dialysis
Time Frame
5 weeks
Title
serum free fatty acids
Description
Change during dialysis
Time Frame
5 weeks
Title
Time to recover from dialysis
Description
Change between dialysates
Time Frame
5 weeks
Title
Dialysis symptom questionnaire
Description
Change between dialysates
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Abramowitz, MD, MS
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Comparison of High Versus Low Bicarbonate Hemodialysis

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