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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
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Davies, Simon J., Caskey, Fergus J., Coyle, David, Lindley, Elizabeth, Macdonald, Jamie, Mitra, Sandip, Wilkie, Martin, Davenport, Andrew, Farrington, Ken, Dasgupta, Indranil, Ormandy, Paula, Andronis, L. (Lazaros) , Solis-Trapala, Ivonne and Sim, Julius (2017) 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, 18 (1). 138. doi:10.1186/s12882-017-0554-1 ISSN 1471-2369.
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Official URL: http://dx.doi.org/10.1186/s12882-017-0554-1
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.
Item Type: | Journal Article | ||||||
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Subjects: | R Medicine > RC Internal medicine | ||||||
Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences > Population, Evidence & Technologies (PET) Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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Library of Congress Subject Headings (LCSH): | Hemodialysis, Kidneys -- Diseases -- Treatment, Clinical trials | ||||||
Journal or Publication Title: | BMC Nephrology | ||||||
Publisher: | BioMed Central Ltd. | ||||||
ISSN: | 1471-2369 | ||||||
Official Date: | 26 April 2017 | ||||||
Dates: |
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Volume: | 18 | ||||||
Number: | 1 | ||||||
Article Number: | 138 | ||||||
DOI: | 10.1186/s12882-017-0554-1 | ||||||
Status: | Peer Reviewed | ||||||
Publication Status: | Published | ||||||
Access rights to Published version: | Open Access (Creative Commons) | ||||||
Date of first compliant deposit: | 23 October 2017 | ||||||
Date of first compliant Open Access: | 23 October 2017 | ||||||
Funder: | National Institute for Health Research Health Technology Assessment (Great Britain) (NIHR HTA) | ||||||
Grant number: | Grant number: 14/216/01 (NIHR HTA) |
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