Comparison of Standard Versus Low Bicarbonate Hemodialysis

Phase 1

Completed

• Conditions: Chronic Kidney Disease; Metabolic Acidosis
• Interventions: Other: Low bicarbonate dialysis

• Registration Number: NCT01777178
• Lead Sponsor: Albert Einstein College of Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-24
• Study First Submitted QC: 2013-01-24
• Study First Posted: 2013-01-28
• Status Verified: 2013-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Last Update Submitted: 2019-04-26
• Last Update Posted: 2019-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low bicarbonate dialysis	Low bicarbonate dialysis	-

Primary Outcome Measures

Name	Time	Method
Post-dialysis pH	1-2 weeks
Change in beta-hydroxybutyrate clearance	1-2 weeks	Comparison between 2 hemodialysis treatments with different bicarbonate dialysis concentrations
Change in lactate clearance	1-2 weeks	Comparison between 2 hemodialysis treatments with different bicarbonate dialysis concentrations
Post-dialysis bicarbonate	1-2 weeks

Trial Locations

Locations (1)

Montefiore Medical Center/Jack D. Weiler Hospital; 🇺🇸 Bronx, New York, United States