Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00291603
Status:
COMPLETED
Last Update Posted:
2007-04-25
First Post:
2006-02-13
Brief Title:
Short Term Effects of FX Dialysers on QOL and Inflammation
Sponsor:
Sir Charles Gairdner Hospital
Organization:
Sir Charles Gairdner Hospital
Study Overview
Official Title:
Short-Term Effects of the FX-Class of Haemodialyser on Quality of Life and Inflammatory Markers in Stable Dialysis Patients
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
1 To assess the short-term effects of the FX-class Dialyser on quality of life in stable haemodialysis patients
2 To assess the short-term effects of the FX-class Dialyser on inflammatory markers in stable haemodialysis patients
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
1 To assess the short-term effects of the FX-class Dialyser on quality of life in stable haemodialysis patients
2 To assess the short-term effects of the FX-class Dialyser on inflammatory markers in stable haemodialysis patients
Detailed Description:
Methods Patient selection All patients in the Joondalup Health Campus satellite dialysis unit will be invited to participate in this study
Inclusion criteria -
1 Age 18years
2 Able to provide informed consent
3 On haemodialysis for 3 months
Exclusion criteria -
1 Active inflammatory infective or neoplastic process within the last 1 month
2 Active major psychiatric condition
3 Currently on haemodiafiltration as haemodialysis modality
Design This study will involve an unblinded cross-over design with patients being randomised upon entry into one of 2 groups The 2 groups will be - 1 HF80 dialyser this is the best of the currently used dialysers and therefore no participant will require a reduction in their dialysis during this trial and 2 FX dialyser Patients will have baseline tests performed prior to intervention and then repeated after 3 months At 3 months patients will then cross-over into the other group and tests repeated after a further 6 months
Due to the nature of the intervention blinding will not be practical The cross-over design will allow maximum power for this fixed and relatively small dialysis population 50 patients
Independent variables -
1 Dialysis prescription on enrolment
a Including dialyser type biocompatibility
2 Adequacy of dialysis
1 Urea reduction ratio
2 KtV
3 Anaemia
1 Including iron studies
2 Including erythropoietin usage
4 Calcium phosphate balance
a Including Parathyroid hormone levels
5 Serum albumin
Outcome markers -
1 Quality of Life i KD-QOL - this is a standardised quality of life questionnaire designed and validated for dialysis patients that will be readily comparable to other studies
ii Feeling thermometer
2 Inflammatory markers i High sensitivity c-reactive protein ii IL-6 iii White cell count
Statistical analysis
Quality of life measures and inflammatory markers will be analysed using paired t-test after normality demonstrated Simple and multiple linear regression analysis will then be performed to examine associations between independent variables with changes in the outcome variables STATA 82 will be used to assist with the analysis
Inclusion criteria -
1 Age 18years
2 Able to provide informed consent
3 On haemodialysis for 3 months
Exclusion criteria -
1 Active inflammatory infective or neoplastic process within the last 1 month
2 Active major psychiatric condition
3 Currently on haemodiafiltration as haemodialysis modality
Design This study will involve an unblinded cross-over design with patients being randomised upon entry into one of 2 groups The 2 groups will be - 1 HF80 dialyser this is the best of the currently used dialysers and therefore no participant will require a reduction in their dialysis during this trial and 2 FX dialyser Patients will have baseline tests performed prior to intervention and then repeated after 3 months At 3 months patients will then cross-over into the other group and tests repeated after a further 6 months
Due to the nature of the intervention blinding will not be practical The cross-over design will allow maximum power for this fixed and relatively small dialysis population 50 patients
Independent variables -
1 Dialysis prescription on enrolment
a Including dialyser type biocompatibility
2 Adequacy of dialysis
1 Urea reduction ratio
2 KtV
3 Anaemia
1 Including iron studies
2 Including erythropoietin usage
4 Calcium phosphate balance
a Including Parathyroid hormone levels
5 Serum albumin
Outcome markers -
1 Quality of Life i KD-QOL - this is a standardised quality of life questionnaire designed and validated for dialysis patients that will be readily comparable to other studies
ii Feeling thermometer
2 Inflammatory markers i High sensitivity c-reactive protein ii IL-6 iii White cell count
Statistical analysis
Quality of life measures and inflammatory markers will be analysed using paired t-test after normality demonstrated Simple and multiple linear regression analysis will then be performed to examine associations between independent variables with changes in the outcome variables STATA 82 will be used to assist with the analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None