Short Term Effects of FX Dialysers on QOL and Inflammation - Full Text View

Sponsored by:	Sir Charles Gairdner Hospital
Information provided by:	Sir Charles Gairdner Hospital
ClinicalTrials.gov Identifier:	NCT00291603

Purpose

Background:

The new hollow fibre FX-class of dialysers (Fresenius Medical Care, Bad Homburg, Germany) features a number of technological improvements that may benefit the patient. This includes the use of the advanced high-flux polysulfone membrane, Helixone®, which has an extremely high endotoxin retaining capability. Theoretically leading to reduced systemic inflammation in the patient, which is an important factor for morbidity and mortality with dialysis.

The dialysis membrane is the first to be manufactured using membrane-spinning procedures (nano-controlled spinning technology) that enables the membrane to be modulated at the nano-scale level. The resultant membrane is able to extremely efficiently remove middle molecules, along with minimal loss of albumin.

These features may lead to improved patient outcomes, including reduced systemic inflammation and improved quality of life.

Aims:

To assess the short-term effects of the FX-class Dialyser on quality of life in stable haemodialysis patients
To assess the short-term effects of the FX-class Dialyser on inflammatory markers in stable haemodialysis patients.

Condition	Intervention	Phase
Kidney Failure, Chronic	Device: FX-class of dialyser	Phase IV

MedlinePlus related topics: Dialysis Kidney Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Official Title:	Short-Term Effects of the FX-Class of Haemodialyser on Quality of Life and Inflammatory Markers in Stable Dialysis Patients

Further study details as provided by Sir Charles Gairdner Hospital:

Primary Outcome Measures:

KD-QOL
Feeling Thermometer

Secondary Outcome Measures:

IL-6
TNF-alpha
hs-CRP
white cell count

Estimated Enrollment:	50
Study Start Date:	February 2006
Study Completion Date:	December 2006

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age >18years
Able to provide informed consent
On haemodialysis for 3 months

Exclusion Criteria:

Active inflammatory, infective or neoplastic process within the last 1 month
Active major psychiatric condition
Currently on haemodiafiltration as haemodialysis modality

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00291603

Locations

Australia, Western Australia
Joondalup Health Campus Satellite Dialysis Unit
Perth, Western Australia, Australia, 6050

Sponsors and Collaborators

Sir Charles Gairdner Hospital

Investigators

Principal Investigator:

Neil C Boudville, MD

University of Western Australia

More Information

Study ID Numbers:	2005-192
Study First Received:	February 13, 2006
Last Updated:	April 24, 2007
ClinicalTrials.gov Identifier:	NCT00291603
Health Authority:	Australia: Human Research Ethics Committee

Keywords provided by Sir Charles Gairdner Hospital:

dialysis
Renal Dialysis
inflammation
quality of life
End Stage Kidney Failure

Study placed in the following topic categories:

Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic

Quality of Life
Kidney Diseases
Inflammation
Kidney Failure

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009