A Clinical Trial of IntensiVE Dialysis
- Conditions
- UremiaRenal Replacement TherapyRenal DialysisEnd Stage Renal DiseaseEnd Stage Kidney Disease
- Interventions
- Procedure: haemodialysis
- 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
- Arm && Interventions
Group Intervention Description standard hours haemodialysis 18 or less hours per week of hemodialysis extended hours haemodialysis 24 or more hours per week of hemodialysis
- 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)
Huaxi Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China
Sydney Dialysis Centre
🇦🇺Sydney, New South Wales, Australia
Sydney Adventist Hospital
🇦🇺Sydney, New South Wales, Australia
Liverpool Hospital
🇦🇺Sydney, New South Wales, Australia
St Michael's Hospital
🇨🇦Toronto, Ontario, Canada
First Affiliated Hospital of Chinese PLA General Hospital
🇨🇳Haidian District, Beijing, China
Sir Charles Gairdner Hospital
🇦🇺Perth, Western Australia, Australia
UBC
🇨🇦Vancouver, British Columbia, Canada
University Health Network
🇨🇦Toronto, Ontario, Canada
Austin Hospital
🇦🇺Melbourne, Victoria, Australia
Monash Medical Centre
🇦🇺Melbourne, Victoria, Australia
The Canberra Hospital
🇦🇺Canberra, Australian Capital Territory, Australia
RPAH/Concord
🇦🇺Sydney, New South Wales, Australia
Gold Coast Hospital
🇦🇺Gold Coast, Queensland, Australia
Nambour General Hospital
🇦🇺Nambour, Queensland, Australia
Princess Alexandra Hospital
🇦🇺Brisbane, Queensland, Australia
Royal Melbourne Hospital
🇦🇺Melbourne, Victoria, Australia
Royal Brisbane Hospital
🇦🇺Brisbane, Queensland, Australia
Royal Hobart Hospital
🇦🇺Hobart, Tasmania, Australia
Beijing Hospital of Traditional Chinese Medicine
🇨🇳Beijing, Beijing, China
Civil Aviation General Hospital
🇨🇳Chaoyang District,, Beijing, China
Beijing Tongren Hospital
🇨🇳Beijing, Beijing, China
Beijing Hospital
🇨🇳Xicheng District, Beijing, China
China-Japan Friendship Hospital
🇨🇳Chaoyang District, Beijing, China
Peking University People's Hospital
🇨🇳Xicheng District, Beijing, China
Shenzhen Hospital of Peking University
🇨🇳Shenzhen, Guangdong, China
Shijiazhuang First People's Hospital
🇨🇳Shijiazhuang, Hebei, China
Fourth Hospital Affiliated to Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Zhengzhou University affiliated first hospital
🇨🇳Zhengzhou, Henan, China
Third Hospital Affiliated to Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
First Affiliated Hospital of Inner Mongolia, Baotou Medical College
🇨🇳Baotou, Inner Mongolia, China
Fourth Hospital Affiliated to Jilin University (FAW General Hospital)
🇨🇳Changchun, Jilin, China
Shanghai Ruijin Hospital
🇨🇳Shanghai, Shanghai, China
Zhongda Hospital, Southeast University
🇨🇳Nanjing, Jiangsu, China
The Chinese PLA Shanghai 85th Hospital
🇨🇳Shanghai, Shanghai, China
Dalian Medical affiliated first hospital
🇨🇳Dalian, Liaoning, China
The second affiliated hospital of Shanxi Medical University
🇨🇳Taiyuan City, Shanxi, China
Auckland City Hospital
🇳🇿Auckland, New Zealand
North Shore Hospital
🇳🇿Auckland, New Zealand
Peking University First Hospital
🇨🇳Xicheng District, Beijing, China