Comparison of Standard Versus Low Bicarbonate Hemodialysis

This study has been completed.
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: June 24, 2013
Last verified: June 2013
  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:


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 ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 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: June 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 July 22, 2014