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Comparison of Standard Versus Low Bicarbonate Hemodialysis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01777178
First Posted: January 28, 2013
Last Update Posted: June 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Matthew Abramowitz, Albert Einstein College of Medicine of Yeshiva University
  Purpose
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 Intervention Phase
Chronic Kidney Disease Metabolic Acidosis Other: Low bicarbonate dialysis Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Matthew Abramowitz, Albert Einstein College of Medicine of Yeshiva University:

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

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

  • Post-dialysis pH [ Time Frame: 1-2 weeks ]
  • Post-dialysis bicarbonate [ Time Frame: 1-2 weeks ]

Enrollment: 10
Study Start Date: January 2013
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low bicarbonate dialysis Other: Low bicarbonate dialysis

  Eligibility

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
  Contacts and Locations
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.
  More Information

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 Submitted: January 24, 2013
First Posted: January 28, 2013
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