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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02098356
Other study ID # 2012-480
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2014
Est. completion date December 2016

Study information

Verified date April 2018
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 hemodialysis treatment with a standard, high-bicarbonate dialysis bath versus a lower bicarbonate dialysis bath, and will compare intradialytic acid-base changes and overall control of metabolic acidosis with the 2 treatment regimens.


Description:

This study will compare hemodialysis treatment with a standard, high-bicarbonate dialysis bath versus a lower bicarbonate dialysis bath, and will compare intradialytic acid-base changes and overall control of metabolic acidosis with the 2 treatment regimens. These parameters will be assessed in patients currently receiving high-bicarbonate hemodialysis as part of usual care. They will then be switched to a lower bicarbonate prescription, after which these parameters will be reassessed. The study will also examine changes in inflammatory markers, glycemic control, ketogenesis, and lipolysis.


Recruitment information / eligibility

Status Completed
Enrollment 7
Est. completion date December 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria:

- Age >18

- Receiving chronic thrice-weekly conventional hemodialysis for at least 6 months

Exclusion Criteria:

- Use of oral alkali within the previous month

- Hospitalization within the previous month

- Inability to provide written informed consent

- Plans for kidney transplant in the next 2 months

- Planned change in phosphate binder therapy within the next month

- Pregnancy, or planned pregnancy in the next 2 months

Study Design


Intervention

Other:
Low Bicarbonate
Low bicarbonate hemodialysis - 30 mEq/L dialysate bicarbonate

Locations

Country Name City State
United States Albert Einstein College of Medicine 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 Pre-dialysis serum bicarbonate Change in predialysis bicarbonate 5 weeks
Secondary serum beta-hydroxybutyrate Change in beta-hydroxybutyrate during dialysis 5 weeks
Secondary beta-hydroxybutyrate clearance Change in clearance between different dialysates 5 weeks
Secondary interleukin-6 Change during dialysis 5 weeks
Secondary serum free fatty acids Change during dialysis 5 weeks
Secondary Time to recover from dialysis Change between dialysates 5 weeks
Secondary Dialysis symptom questionnaire Change between dialysates 5 weeks
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