Design and participant baseline characteristics of 'A Clinical Trial of IntensiVE Dialysis': The ACTIVE Dialysis Study

Jardine, Meg J., Zuo, Li, Gray, Nicholas A., De Zoysa, Janak, Chan, Christopher T., Gallagher, Martin P., Howard, Kirsten, Hertier, Stephane, Cass, Alan, Perkovic, Vlado and ACTIVE Dialysis Steering Committee (2015) Design and participant baseline characteristics of 'A Clinical Trial of IntensiVE Dialysis': The ACTIVE Dialysis Study. Nephrology, 20 4: 257-265. doi:10.1111/nep.12385


Author Jardine, Meg J.
Zuo, Li
Gray, Nicholas A.
De Zoysa, Janak
Chan, Christopher T.
Gallagher, Martin P.
Howard, Kirsten
Hertier, Stephane
Cass, Alan
Perkovic, Vlado
ACTIVE Dialysis Steering Committee
Title Design and participant baseline characteristics of 'A Clinical Trial of IntensiVE Dialysis': The ACTIVE Dialysis Study
Journal name Nephrology   Check publisher's open access policy
ISSN 1440-1797
1320-5358
Publication date 2015-04-01
Sub-type Article (original research)
DOI 10.1111/nep.12385
Volume 20
Issue 4
Start page 257
End page 265
Total pages 9
Place of publication Richmond, VIC, Australia
Publisher Wiley-Blackwell Publishing Asia
Collection year 2016
Language eng
Formatted abstract
Aims: Observational reports suggest extended dialysis hours are associated with improved outcomes. These findings are confounded by better prognostic characteristics among people practising extended hours. The aim of this article is to provide an overview of the methods and baseline characteristics for ACTIVE Dialysis Study participants.

Methods: This multicentre, randomized, open-label, blinded endpoint-assessment trial randomized participants receiving maintenance haemodialysis therapy to either extended (≥24 h) or standard (12–18 h) weekly haemodialysis for 12 months. A web-based randomization system used minimization to ensure balanced allocation across regions, dialysis setting and dialysis vintage. The primary outcome is the change in quality of life over 12 months of study treatment assessed by EQ-5D. Secondary outcomes include change in left ventricular mass index assessed by magnetic resonance imaging and safety outcomes including dialysis access events.

Results: A total of 200 participants were recruited between 2009 and 2013 from Australia (29.0%), China (62.0%), Canada (5.5%) and New Zealand (3.5%). Participants had a mean age of 52 (± 12) years and 11.5% were dialysing at home, with a mean duration of 13.9 h per week over a median of three sessions. At baseline, 32.5% had a history of cardiovascular disease and 36.5% had diabetes.

Conclusion: The ACTIVE Dialysis Study has met its planned recruitment target. The participant population are drawn from a range of health service settings in a global context. The study will contribute important evidence on the benefits and harms of extending weekly dialysis hours.
Keyword Extended dialysis
H(a)emodialysis
Left ventricular mass index
Quality of life
Randomized controlled trial
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2016 Collection
School of Medicine Publications
 
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