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Comparison of Standard Versus Low Bicarbonate Hemodialysis

This study is currently recruiting participants.
Verified January 2013 by Albert Einstein College of Medicine of Yeshiva University
Sponsor:
Information provided by (Responsible Party):
Matthew Abramowitz, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT01777178
First received: January 24, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Change in beta-hydroxybutyrate clearance [ Time Frame: 1-2 weeks ] [ Designated as safety issue: No ]
    Comparison between 2 hemodialysis treatments with different bicarbonate dialysis concentrations

  • Change in lactate clearance [ Time Frame: 1-2 weeks ] [ Designated as safety issue: No ]
    Comparison between 2 hemodialysis treatments with different bicarbonate dialysis concentrations

  • Post-dialysis pH [ Time Frame: 1-2 weeks ] [ Designated as safety issue: No ]
  • Post-dialysis bicarbonate [ Time Frame: 1-2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: January 2013
Estimated Study Completion Date: June 2013
Estimated 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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01777178

Contacts
Contact: William Paredes 718-430-3088 bill.paredes@einstein.yu.edu

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

No publications provided

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
Study First Received: January 24, 2013
Last Updated: January 24, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 22, 2013