End Stage Renal Disease Clinical Trial
Official title:
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.
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