Rationale and design of BISTRO: a randomized controlled trial to determine whether bioimpedance spectroscopy-guided fluid management maintains residual kidney function in incident haemodialysis patients

BMC Nephrology

Study Protocol

Lazaros Andronis¹  Ivonne Solis-Trapala²  Julius Sim²  Simon J. Davies³  David Coyle⁴  Sandip Mitra⁵  Elizabeth Lindley⁶  Ken Farrington⁷  Indranil Dasgupta⁸  Andrew Davenport⁹  Martin Wilkie^1,10  Paula Ormandy^1,11  Jamie Macdonald^1,12  Fergus J. Caskey^1,13 

[1] Health Economics Unit, University of Birmingham, Birmingham, UK;Institute for Applied Clinical Sciences, Keele University, Keele, Staffordshire, UK;Institute for Applied Clinical Sciences, Keele University, Keele, Staffordshire, UK;University Hospital of North Midlands, Newcastle Rd, ST46QG, Stoke-on-Trent, Staffordshire, UK;NIHR Devices for Dignity, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK;NIHR Devices for Dignity, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK;Renal Medicine, Central Manchester University Hospitals NHS Foundation Trust, Manchester, UK;NIHR Devices for Dignity, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK;Renal Medicine, Leeds Teaching Hospitals NHS Trust, Leeds, UK;Renal Medicine, East & North Hertfordshire NHS Trust, Hertfordshire, UK;Renal Medicine, Heart of England NHS Foundation Trust, Birmingham, UK;Renal Medicine, Royal Free Hampstead NHS Trust, London, UK;Renal Medicine, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK;School of Nursing, Midwifery, Social Work and Social Science, University of Salford, Manchester, UK;School of Sport, Health and Exercise Sciences, Bangor University, Bangor, North Wales, UK;UK Renal Registry and School of Social and Community Medicine, University of Bristol, Bristol, UK;

关键词: Fluid status;    Body compostion;    Residual kidney function;    Haemodialysis;    Bioimpedance;    Fluid management;    Health economics;   

DOI  :  10.1186/s12882-017-0554-1

 received in 2017-02-17, accepted in 2017-04-13,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundPreserved 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.Methods/Design516 pateints 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.DiscussionThis 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.Trial registrationISCCTN Number: 11342007, completed 26/04/2016; NIHR Portfolio number: CPMS31766; Sponsor: Keele University

【 授权许可】

CC BY   
© The Author(s). 2017