A Clinical Trial of IntensiVE Dialysis

Phase 4

Completed

• Conditions: Uremia; Renal Replacement Therapy; Renal Dialysis; End Stage Renal Disease; End Stage Kidney Disease

• 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.

Study Timeline

• Study First Submitted: 2008-03-25
• Study First Submitted QC: 2008-03-31
• Study First Posted: 2008-04-01
• Study Start: 2008-05
• Primary Completion: 2014-07
• Study Completion: 2014-10
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-01
• Last Update Posted: 2019-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Incident or prevalent patients requiring maintenance haemodialysis therapy for ESKD
2. Aged 18 years or older
3. Undergoing dialysis for 18 hours per week or less
4. Suitable for either extended or standard dialysis in the view of the treating physician
5. Agreeable to randomisation

Exclusion Criteria

1. Life expectancy of less than 6 months
2. Definite plans to undergo renal transplantation within 12 months of entry to the study
3. Inability to complete quality of life questionnaire
4. Concomitant major illness that would limit assessments and followup
5. 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

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)

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

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