A Phase 4 interventional study of haemodialysis in Renal Replacement Therapy, Renal Dialysis and End Stage Kidney Disease, sponsored by The George Institute. Completed at 40 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-03.
Sponsored by The George Institute · Phase 4, Interventional, and Treatment
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.
2,121 studies on the registry are indexed under Kidney Failure, Chronic; 264 are open to participants now.
This study's enrollment of 200 is above the median of 55 across 1,582 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →The George Institute is the lead sponsor of 56 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
24 or more hours per week of hemodialysis
Procedure: haemodialysis
18 or less hours per week of hemodialysis
Procedure: haemodialysis
Comparison of different weekly duration of haemodialysis treatment
Also known as: Dialysis, Renal replacement therapy
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.
Time frame: 12 months from randomisation
Survival and cardiovascular analyses
Time frame: 12 months
Quality of life and patient acceptability
Time frame: 12 months
Safety outcomes
Time frame: 12 months
Costs associated with each intervention
Time frame: 12 months
Changes in biochemical and haematological parameters
Time frame: 12 months
The record gives a start of May 2008, a primary completion of Jul 2014 and a completion of Oct 2014. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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The George Institute