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

Autor: David Coyle, Elizabeth Lindley, Paula Ormandy, Julius Sim, Martin Wilkie, Simon J. Davies, Jamie H. Macdonald, Sandip Mitra, Ivonne Solis-Trapala, Fergus Caskey, Lazaros Andronis, Ken Farrington, Andrew Davenport, Indranil Dasgupta
Jazyk: angličtina
Rok vydání: 2017
Předmět:
Nephrology
Male
medicine.medical_treatment
030232 urology & nephrology
Water-Electrolyte Imbalance
030204 cardiovascular system & hematology
lcsh:RC870-923
Kidney Function Tests
law.invention
Study Protocol
0302 clinical medicine
Randomized controlled trial
Quality of life
law
Fluid management
Cumulative incidence
Renal Insufficiency
Aged
80 and over
Bioimpedance
Middle Aged
Combined Modality Therapy
Haemodialysis
Treatment Outcome
Body compostion
Dielectric Spectroscopy
Body Composition
Female
medicine.symptom
Fluid status
Adult
medicine.medical_specialty
Renal function
Residual kidney function
Sensitivity and Specificity
RC648
03 medical and health sciences
Young Adult
Health Economics
Renal Dialysis
Internal medicine
bioimpedance
Journal Article
medicine
Humans
Dialysis
Aged
business.industry
Reproducibility of Results
lcsh:Diseases of the genitourinary system. Urology
Transplantation
Quality of Life
Fluid Therapy
Anuria
business
Health economics
RC
Zdroj: BMC Nephrology
Davies, S J, Caskey, F J, Coyle, D, Lindley, E, Macdonald, J, Mitra, S, Wilkie, M, Davenport, A, Farrington, K, Dasgupta, I, Ormandy, P, Andronis, L, Solis-Trapala, I & Sim, J 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, vol. 18, no. 1, pp. 138 . https://doi.org/10.1186/s12882-017-0554-1
Davies, S J, Caskey, F J, Coyle, D, Lindley, E, MacDonald, J, Mitra, S, Wilkie, M, Davenport, A, Farrington, K, Dasgupta, I, Ormandy, P, Andronis, L, Solis-Trapala, I & Sim, J 2017, ' Rationale and design of BISTRO : a randomized controlled trial to determine whether bioimpedance spectroscopyguided fluid management maintains residual kidney function in incident haemodialysis patients ', BMC Nephrology, vol. 18, 138 . https://doi.org/10.1186/s12882-017-0554-1
BMC Nephrology, Vol 18, Iss 1, Pp 1-11 (2017)
ISSN: 1471-2369
DOI: 10.1186/s12882-017-0554-1
Popis: 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
Databáze: OpenAIRE
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