Short Term Effects of FX Dialysers on QOL and Inflammation
|ClinicalTrials.gov Identifier: NCT00291603|
Recruitment Status : Completed
First Posted : February 14, 2006
Last Update Posted : April 25, 2007
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.
- 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 or disease||Intervention/treatment||Phase|
|Kidney Failure, Chronic||Device: FX-class of dialyser||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Short-Term Effects of the FX-Class of Haemodialyser on Quality of Life and Inflammatory Markers in Stable Dialysis Patients|
|Study Start Date :||February 2006|
|Study Completion Date :||December 2006|
- Feeling Thermometer
- white cell count
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00291603
|Australia, Western Australia|
|Joondalup Health Campus Satellite Dialysis Unit|
|Perth, Western Australia, Australia, 6050|
|Principal Investigator:||Neil C Boudville, MD||The University of Western Australia|