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
Abstract 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 r...
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doaj-db3844702496486e9f1aef944b5feadb2020-11-25T00:31:50ZengBMCBMC Nephrology1471-23692017-04-0118111110.1186/s12882-017-0554-1Rationale and design of BISTRO: a randomized controlled trial to determine whether bioimpedance spectroscopy-guided fluid management maintains residual kidney function in incident haemodialysis patientsSimon J. Davies0Fergus J. Caskey1David Coyle2Elizabeth Lindley3Jamie Macdonald4Sandip Mitra5Martin Wilkie6Andrew Davenport7Ken Farrington8Indranil Dasgupta9Paula Ormandy10Lazaros Andronis11Ivonne Solis-Trapala12Julius Sim13Institute for Applied Clinical Sciences, Keele UniversityUK Renal Registry and School of Social and Community Medicine, University of BristolNIHR Devices for Dignity, Sheffield Teaching Hospitals NHS Foundation TrustNIHR Devices for Dignity, Sheffield Teaching Hospitals NHS Foundation TrustSchool of Sport, Health and Exercise Sciences, Bangor UniversityNIHR Devices for Dignity, Sheffield Teaching Hospitals NHS Foundation TrustRenal Medicine, Sheffield Teaching Hospitals NHS Foundation TrustRenal Medicine, Royal Free Hampstead NHS TrustRenal Medicine, East & North Hertfordshire NHS TrustRenal Medicine, Heart of England NHS Foundation TrustSchool of Nursing, Midwifery, Social Work and Social Science, University of SalfordHealth Economics Unit, University of BirminghamInstitute for Applied Clinical Sciences, Keele UniversityInstitute for Applied Clinical Sciences, Keele UniversityAbstract 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. Methods/Design 516 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. 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. Trial registration ISCCTN Number: 11342007 , completed 26/04/2016; NIHR Portfolio number: CPMS31766; Sponsor: Keele Universityhttp://link.springer.com/article/10.1186/s12882-017-0554-1Fluid statusBody compostionResidual kidney functionHaemodialysisBioimpedanceFluid management |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Simon J. Davies Fergus J. Caskey David Coyle Elizabeth Lindley Jamie Macdonald Sandip Mitra Martin Wilkie Andrew Davenport Ken Farrington Indranil Dasgupta Paula Ormandy Lazaros Andronis Ivonne Solis-Trapala Julius Sim |
spellingShingle |
Simon J. Davies Fergus J. Caskey David Coyle Elizabeth Lindley Jamie Macdonald Sandip Mitra Martin Wilkie Andrew Davenport Ken Farrington Indranil Dasgupta Paula Ormandy Lazaros Andronis Ivonne Solis-Trapala Julius Sim 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 Fluid status Body compostion Residual kidney function Haemodialysis Bioimpedance Fluid management |
author_facet |
Simon J. Davies Fergus J. Caskey David Coyle Elizabeth Lindley Jamie Macdonald Sandip Mitra Martin Wilkie Andrew Davenport Ken Farrington Indranil Dasgupta Paula Ormandy Lazaros Andronis Ivonne Solis-Trapala Julius Sim |
author_sort |
Simon J. Davies |
title |
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 |
title_short |
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 |
title_full |
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 |
title_fullStr |
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 |
title_full_unstemmed |
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 |
title_sort |
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 |
publisher |
BMC |
series |
BMC Nephrology |
issn |
1471-2369 |
publishDate |
2017-04-01 |
description |
Abstract 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. Methods/Design 516 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. 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. Trial registration ISCCTN Number: 11342007 , completed 26/04/2016; NIHR Portfolio number: CPMS31766; Sponsor: Keele University |
topic |
Fluid status Body compostion Residual kidney function Haemodialysis Bioimpedance Fluid management |
url |
http://link.springer.com/article/10.1186/s12882-017-0554-1 |
work_keys_str_mv |
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