A Clinical Trial of IntensiVE Dialysis
- Conditions
- UremiaRenal Replacement TherapyRenal DialysisEnd Stage Renal DiseaseEnd Stage Kidney Disease
- Registration Number
- NCT00649298
- Lead Sponsor
- The George Institute
- Brief Summary
This study will assess clinical outcomes of extended weekly hours of haemodialysis (\>= 24 hours per week) compared with standard hours of haemodialysis (\<=18 hours/week) in people with ESKD.
- Detailed Description
A rapidly increasing volume of observational data suggests substantial benefits may be associated with an increased duration of dialysis. As well as improved quality of life, improved functioning and beneficial changes in a variety of laboratory parameters, it has been suggested that extended dialysis sessions might reduce mortality and major morbidity. Uncontrolled data from centres that have been providing extended dialysis shows dramatically lower mortality rates compared to those observed in centres providing standard duration dialysis. Recent analyses of extended dialysis conclude that the savings achieved in drug and hospitalization costs may lead to an overall reduction in costs compared with traditional forms of dialysis.
In this trial, we propose to examine the effects of extended dialysis (24 hours weekly or more) compared to standard dialysis (18 hours or less weekly) in patients with ESKD. The proposed study is a multi-centre, open label, randomised, controlled trial.
The study began with a pilot phase which was converted to the current main study on the receipt of peer-reviewed funding for the full study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- Incident or prevalent patients requiring maintenance haemodialysis therapy for ESKD
- Aged 18 years or older
- Undergoing dialysis for 18 hours per week or less
- Suitable for either extended or standard dialysis in the view of the treating physician
- Agreeable to randomisation
- Life expectancy of less than 6 months
- Definite plans to undergo renal transplantation within 12 months of entry to the study
- Inability to complete quality of life questionnaire
- Concomitant major illness that would limit assessments and followup
- High chance that the patient will not adhere to study treatment and follow up in the view of the treating physician.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The primary end-point for this study is the difference in the change in quality of life between the two groups from randomisation to the 12 month follow-up as measured by the EQ-5D instrument. 12 months from randomisation
- Secondary Outcome Measures
Name Time Method Quality of life and patient acceptability 12 months Changes in biochemical and haematological parameters 12 months Safety outcomes 12 months Costs associated with each intervention 12 months Survival and cardiovascular analyses 12 months
Trial Locations
- Locations (40)
The Canberra Hospital
🇦🇺Canberra, Australian Capital Territory, Australia
RPAH/Concord
🇦🇺Sydney, New South Wales, Australia
Sydney Adventist Hospital
🇦🇺Sydney, New South Wales, Australia
Liverpool Hospital
🇦🇺Sydney, New South Wales, Australia
Sydney Dialysis Centre
🇦🇺Sydney, New South Wales, Australia
Princess Alexandra Hospital
🇦🇺Brisbane, Queensland, Australia
Royal Brisbane Hospital
🇦🇺Brisbane, Queensland, Australia
Gold Coast Hospital
🇦🇺Gold Coast, Queensland, Australia
Nambour General Hospital
🇦🇺Nambour, Queensland, Australia
Royal Hobart Hospital
🇦🇺Hobart, Tasmania, Australia
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