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Comparison of Standard Versus Low Bicarbonate Hemodialysis

Primary Purpose

Chronic Kidney Disease, Metabolic Acidosis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Low bicarbonate dialysis
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 bicarbonate, dialysis

Eligibility Criteria

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

Inclusion Criteria:

  • Receiving chronic thrice-weekly conventional hemodialysis for at least 3 months
  • Age > 18 years

Exclusion Criteria:

  • Use of oral alkali within the previous month
  • Hospitalization within the previous month
  • Inability to provide written informed consent
  • Pregnancy

Sites / Locations

  • Montefiore Medical Center/Jack D. Weiler Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Low bicarbonate dialysis

Arm Description

Outcomes

Primary Outcome Measures

Change in beta-hydroxybutyrate clearance
Comparison between 2 hemodialysis treatments with different bicarbonate dialysis concentrations
Change in lactate clearance
Comparison between 2 hemodialysis treatments with different bicarbonate dialysis concentrations
Post-dialysis pH
Post-dialysis bicarbonate

Secondary Outcome Measures

Full Information

First Posted
January 24, 2013
Last Updated
April 26, 2019
Sponsor
Albert Einstein College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01777178
Brief Title
Comparison of Standard Versus Low Bicarbonate Hemodialysis
Official Title
Intradialytic Acid-base Changes and Organic Anion Production With Standard Versus Low Bicarbonate Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (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 acid-base changes during hemodialysis treatments with a standard dialysis bath versus a lower bicarbonate dialysis bath, and aims to define the factors that limit equilibration of the bicarbonate concentration in a patient's blood with that in the dialysate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Metabolic Acidosis
Keywords
bicarbonate, dialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low bicarbonate dialysis
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Low bicarbonate dialysis
Primary Outcome Measure Information:
Title
Change in beta-hydroxybutyrate clearance
Description
Comparison between 2 hemodialysis treatments with different bicarbonate dialysis concentrations
Time Frame
1-2 weeks
Title
Change in lactate clearance
Description
Comparison between 2 hemodialysis treatments with different bicarbonate dialysis concentrations
Time Frame
1-2 weeks
Title
Post-dialysis pH
Time Frame
1-2 weeks
Title
Post-dialysis bicarbonate
Time Frame
1-2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Receiving chronic thrice-weekly conventional hemodialysis for at least 3 months Age > 18 years Exclusion Criteria: Use of oral alkali within the previous month Hospitalization within the previous month Inability to provide written informed consent Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew K Abramowitz, MD, MS
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center/Jack D. Weiler Hospital
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Comparison of Standard Versus Low Bicarbonate Hemodialysis

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