Comparison of Conventional Dialysis and the Allient System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2014-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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End Stage Renal Disease Chronic Kidney Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

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).

Group Type EXPERIMENTAL

Allient System

Intervention Type DEVICE

The Allient System uses a different type of blood pump and a lower volume of dialysate.

Interventions

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Allient System

The Allient System uses a different type of blood pump and a lower volume of dialysate.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No