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Comparison of Standard Versus Low Bicarbonate Hemodialysis

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ClinicalTrials.gov Identifier: NCT01777178
Recruitment Status : Completed
First Posted : January 28, 2013
Last Update Posted : June 25, 2013
Sponsor:
Information provided by (Responsible Party):
Matthew Abramowitz, Albert Einstein College of Medicine of Yeshiva University

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Metabolic Acidosis Other: Low bicarbonate dialysis Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intradialytic Acid-base Changes and Organic Anion Production With Standard Versus Low Bicarbonate Hemodialysis
Study Start Date : January 2013
Primary Completion Date : June 2013
Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Low bicarbonate dialysis Other: Low bicarbonate dialysis



Primary Outcome Measures :
  1. Change in beta-hydroxybutyrate clearance [ Time Frame: 1-2 weeks ]
    Comparison between 2 hemodialysis treatments with different bicarbonate dialysis concentrations

  2. Change in lactate clearance [ Time Frame: 1-2 weeks ]
    Comparison between 2 hemodialysis treatments with different bicarbonate dialysis concentrations

  3. Post-dialysis pH [ Time Frame: 1-2 weeks ]
  4. Post-dialysis bicarbonate [ Time Frame: 1-2 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01777178


Locations
United States, New York
Montefiore Medical Center/Jack D. Weiler Hospital
Bronx, New York, United States, 10461
Sponsors and Collaborators
Albert Einstein College of Medicine, Inc.
Investigators
Principal Investigator: Matthew K Abramowitz, MD, MS Albert Einstein College of Medicine, Inc.

Responsible Party: Matthew Abramowitz, Assistant Professor, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT01777178     History of Changes
Other Study ID Numbers: 2012-684
First Posted: January 28, 2013    Key Record Dates
Last Update Posted: June 25, 2013
Last Verified: June 2013

Keywords provided by Matthew Abramowitz, Albert Einstein College of Medicine of Yeshiva University:
bicarbonate
dialysis

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Acidosis
Urologic Diseases
Renal Insufficiency
Acid-Base Imbalance
Metabolic Diseases