Short Term Effects of FX Dialysers on QOL and Inflammation

NCT ID: NCT00291603

Last Updated: 2007-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2006-12-31

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.

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. Kt/V

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 8.2 will be used to assist with the analysis

Conditions

Kidney Failure, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

FX-class of dialyser

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sir Charles Gairdner Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Neil C Boudville, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Western Australia

Locations

Joondalup Health Campus Satellite Dialysis Unit

Perth, Western Australia, Australia

Countries

Australia

Other Identifiers

2005-192

Identifier Type: -

Identifier Source: org_study_id