Comparison of Conventional Dialysis and the Allient System

Not Applicable

• Conditions: End Stage Renal Disease; Chronic Kidney Failure
• Interventions: Device: Allient System

• Registration Number: NCT00788905
• Lead Sponsor: Renal Research Institute

Brief Summary

The purpose of the study to determine whether the level of inflammation may be decreased, the lifespan of red blood cells increased and the clearance of waste products in the blood improved through the use of the Allient System as compared to conventional hemodialysis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-09-23
• Study Start: 2008-11
• Study First Submitted QC: 2008-11-10
• Study First Posted: 2008-11-11
• Primary Completion: 2011-02
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-27
• Last Update Posted: 2013-03-29
• Study Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Maintenance in-center hemodialysis
• Age greater than or equal to 18 years
• Has been on hemodialysis for at least 4 months
• Uses a standard single-pass dialysis machine with a high-flux dialyzer

Exclusion Criteria

• Hospitalization during the 8 weeks preceding enrollment
• Infection requiring antibiotic treatment during the 8 weeks preceding enrollment
• Central venous cather as dialysis access
• Uncontrollable blood coagulation anomalies
• Smokers
• Dialysis regimen other than 3 times weekly
• In ability to understand the English language and give informed consent for participation in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	Allient System	Subject will continue conventional hemodialysis therapy for one week ("no intervention" phase) and then swtich to the Allient system for two weeks ("active comparator" phase).

Primary Outcome Measures

Name	Time	Method
Clearance of specific waste products from blood determined through subject blood and dialysate samples	3 weeks

Secondary Outcome Measures

Name	Time	Method
Inflammation as determined by levels of specific inflammatory markers	3 weeks
Red blood cell lifespan determined through a measurement of CO in the subject's breath	3 weeks

Trial Locations

Locations (3)

Irving Place Dialysis Center; 🇺🇸 New York, New York, United States

Upper Manhattan Dialysis Center; 🇺🇸 New York, New York, United States

Yorkville Dialysis Center; 🇺🇸 New York, New York, United States