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Clinical Trials/NCT00788905
NCT00788905
Unknown
Not Applicable

Uremic Toxin Removal, Blood Cell Kinetics, and Inflammatory Response in Patients Treated With the Allient System

Renal Research Institute3 sites in 1 country40 target enrollmentNovember 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
End Stage Renal Disease
Sponsor
Renal Research Institute
Enrollment
40
Locations
3
Primary Endpoint
Clearance of specific waste products from blood determined through subject blood and dialysate samples
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2008
End Date
January 2014
Last Updated
13 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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
  • Dialysis regimen other than 3 times weekly
  • In ability to understand the English language and give informed consent for participation in the study

Outcomes

Primary Outcomes

Clearance of specific waste products from blood determined through subject blood and dialysate samples

Time Frame: 3 weeks

Secondary Outcomes

  • 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)

Study Sites (3)

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