NCT00649298

A Clinical Trial of IntensiVE Dialysis

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: The George Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Replacement Therapy
• Renal Dialysis
• End Stage Kidney Disease
• End Stage Renal Disease
• Uremia

Interventions

Type	Name	Description
PROCEDURE	haemodialysis	Comparison of different weekly duration of haemodialysis treatment

Timeline

• Start date: 2008-05-01
• Primary completion: 2014-07-01
• Completion: 2014-10-01
• First posted: 2008-04-01
• Last updated: 2019-12-03

Locations

40 sites across 4 countries: Australia, Canada, China, New Zealand