Survival Study in Patients Undergoing On-line Hemodiafiltration

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

906 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2012-01-31

Brief Summary

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Patients on hemodialysis will be randomly assigned (1:1) to continue on conventional hemodialysis or on-line hemodiafiltration, both three times per week. A 3 year follow-up and a sample size of around 750 will be necessary to detect a 35% reduction in mortality.

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Detailed Description

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Conditions

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Hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Hemodialysis

Group Type ACTIVE_COMPARATOR

Hemodialysis

Intervention Type PROCEDURE

3 times per week

B

On-line hemodiafiltration

Group Type EXPERIMENTAL

On-line hemodiafiltration

Intervention Type PROCEDURE

3 times per week

Interventions

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Hemodialysis

3 times per week

Intervention Type PROCEDURE

On-line hemodiafiltration

3 times per week

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age 18 and older
* Currently undergoing hemodialysis
* Clinical stability
* Stable vascular access

Exclusion Criteria

* Chronic inflammatory diseases
* Liver cirrhosis
* Malignancies
* Chronic immunosuppressant or antiinflammatory use
* Dialysis through temporary catheter or single puncture

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No