BioImpedance Spectroscopy to Maintain Renal Output: The BISTRO Trial
Background
Preserved Residual Kidney Function (RKF) and normal fluid status are associated with better patient outcomes in incident haemodialysis patients. The objective of this trial is to determine whether using bioimpedance technology in prescribing the optimal post-dialysis weight can reduce the rate of decline of RKF and potentially improve patient outcomes.
Professor Paula Ormandy from the University of Salford was a co-Investigator on this trial.
Methods/Design
516 patients commencing haemodialysis, aged >18 with RKF of > 3 ml/min/1.73 m2 or a urine volume >500 ml per day or per the shorter inter-dialytic period will be consented and enrolled into a pragmatic, open-label, randomized controlled trial. The intervention is incorporation of bioimpedance spectroscopy (BI) determination of normally hydrated weight to set a post-dialysis target weight that limits volume depletion, compared to current standard practice. Clinicians and participants will be blinded to BI measures in the control group and a standardized record capturing management of fluid status will be used in all participants. Primary outcome is preservation of residual kidney function assessed as time to anuria (≤100 ml/day or ≤200 ml urine volume in the short inter-dialytic period). A sample size of 516 was based upon a cumulative incidence of 30% anuria in the control group and 20% in the treatment group and 11% competing risks (death, transplantation) over 10 months, with up to 2 years follow-up.
Secondary outcomes include rate of decline in small solute clearance, significant adverse events, hospitalization, loss of vascular access, cardiovascular events and interventions, dialysis efficacy and safety, dialysis-related symptoms and quality of life. Economic evaluation will be carried out to determine the cost-effectiveness of the intervention. Analyses will be adjusted for patient characteristics and dialysis unit practice patterns relevant to fluid management.
Discussion
This trial will establish the added value of undertaking BI measures to support clinical management of fluid status and establish the relationship between fluid status and preservation of residual kidney function in incident haemodialysis patients.
Funder
National Institute for Health Research (NIHR) Health Technology Assessment (HTA) assessment
Team
Principal Invetsigator:
Simon J. Davies (PI)
Co-Investigators:
Paula Ormandy, School of Health & Society, University of Salford
Ivonne Solis-Trapala & Julius Sim, Institute for Applied Clinical Sciences, Keele University, Keele, Staffordshire, UK
Fergus J. Caskey, UK Renal Registry and School of Social and Community Medicine, University of Bristol, Bristol, UK
David Coyle, Elizabeth Lindley & Sandip Mitra, NIHR Devices for Dignity, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK
Elizabeth Lindley, Renal Medicine, Leeds Teaching Hospitals NHS Trust, Leeds, UK
Jamie Macdonald, School of Sport, Health and Exercise Sciences, Bangor University, Bangor, North Wales, UK
Sandip Mitra, Renal Medicine, Central Manchester University Hospitals NHS Foundation Trust, Manchester, UK
Martin Wilkie, Renal Medicine, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK
Andrew Davenport, Renal Medicine, Royal Free Hampstead NHS Trust, London, UK
Ken Farrington, Renal Medicine, East & North Hertfordshire NHS Trust, Hertfordshire, UK
Indranil Dasgupta, Renal Medicine, Heart of England NHS Foundation Trust, Birmingham, UK
Lazaros Andronis, Health Economics Unit, University of Birmingham, Birmingham, UK
Publications: