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ACTIVE Dialysis - A Multicentre, Unblinded, Randomised, Controlled Trial to Assess Quality of Life, Clinical Outcomes and Cost Utility for Extended vs Standard Duration of Dialysis in Patients With End Stage Kidney Disease.
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
May 1, 2008
Primary Completion Date
July 1, 2014
Completion Date
October 1, 2014
Last Updated
December 3, 2019
200
ACTUAL participants
haemodialysis
PROCEDURE
Lead Sponsor
The George Institute
Collaborators
NCT06889974
NCT07271420
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05525507