Comparison of Standard Versus Low Bicarbonate Hemodialysis
April 26, 2019 updated by: Matthew Abramowitz, Albert Einstein College of Medicine
Intradialytic Acid-base Changes and Organic Anion Production With Standard Versus Low Bicarbonate Hemodialysis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 1
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
-
-
New York
-
Bronx, New York, United States, 10461
- Montefiore Medical Center/Jack D. Weiler Hospital
-
-
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
15 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Low bicarbonate dialysis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in beta-hydroxybutyrate clearance
Time Frame: 1-2 weeks
|
Comparison between 2 hemodialysis treatments with different bicarbonate dialysis concentrations
|
1-2 weeks
|
|
Change in lactate clearance
Time Frame: 1-2 weeks
|
Comparison between 2 hemodialysis treatments with different bicarbonate dialysis concentrations
|
1-2 weeks
|
|
Post-dialysis pH
Time Frame: 1-2 weeks
|
1-2 weeks
|
|
|
Post-dialysis bicarbonate
Time Frame: 1-2 weeks
|
1-2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Matthew K 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
January 1, 2013
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
January 24, 2013
First Submitted That Met QC Criteria
January 24, 2013
First Posted (Estimate)
January 28, 2013
Study Record Updates
Last Update Posted (Actual)
April 30, 2019
Last Update Submitted That Met QC Criteria
April 26, 2019
Last Verified
June 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012-684
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.