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NCT01777178 Clinical Trial

Comparison of Standard Versus Low Bicarbonate Hemodialysis

Chronic Kidney Disease Clinical Trial

Official title:
Intradialytic Acid-base Changes and Organic Anion Production With Standard Versus Low Bicarbonate Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01777178
Other study ID # 2012-684
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date January 2013
Est. completion date June 2013

Study information
Verified date June 2013
Source Albert Einstein College of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Low bicarbonate dialysis

Locations
Country Name City State
United States Montefiore Medical Center/Jack D. Weiler Hospital Bronx New York

Sponsors (1)
Lead Sponsor Collaborator
Albert Einstein College of Medicine

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in beta-hydroxybutyrate clearance Comparison between 2 hemodialysis treatments with different bicarbonate dialysis concentrations 1-2 weeks
Primary Change in lactate clearance Comparison between 2 hemodialysis treatments with different bicarbonate dialysis concentrations 1-2 weeks
Primary Post-dialysis pH 1-2 weeks
Primary Post-dialysis bicarbonate 1-2 weeks
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