Comparison of High Versus Low Bicarbonate Hemodialysis

Chronic Kidney Disease Clinical Trial

Official title:

Intradialytic Acid-base Changes and Organic Anion Production With High Versus Low Bicarbonate Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02098356
• Other study ID #: 2012-480
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Acidosis
• Chronic Kidney Disease
• End-stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Metabolic Acidosis
• Renal Insufficiency, Chronic

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