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

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

doi:10.1186/s12882-017-0554-1

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

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

Research output: Contribution to journal › Article (Academic Journal) › peer-review

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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

Original language	English
Article number	138
Number of pages	11
Journal	BMC Nephrology
Volume	18
DOIs	https://doi.org/10.1186/s12882-017-0554-1
Publication status	Published - 26 Apr 2017

Keywords

Fluid status
Health Economics
Body Composition
Residual kidney function
Haemodialysis
bioimpedance
Fluid management

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10.1186/s12882-017-0554-1

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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, 18, Article 138. https://doi.org/10.1186/s12882-017-0554-1

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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 ",

keywords = "Fluid status, Health Economics, Body Composition, Residual kidney function, Haemodialysis, bioimpedance, Fluid management",

author = "Davies, {Simon J} and Caskey, {Fergus J} and David Coyle and Elizabeth Lindley and Jamie MacDonald and Sandip Mitra and Martin Wilkie and Andrew Davenport and Ken Farrington and Indranil Dasgupta and Paula Ormandy and Lazaros Andronis and Ivonne Solis-Trapala and Julius Sim",

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Davies, SJ, Caskey, FJ, 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

Rationale and design of BISTRO: a randomized controlled trial to determine whether bioimpedance spectroscopyguided fluid management maintains residual kidney function in incident haemodialysis patients. / Davies, Simon J; Caskey, Fergus J; Coyle, David et al.
In: BMC Nephrology, Vol. 18, 138, 26.04.2017.

Research output: Contribution to journal › Article (Academic Journal) › peer-review

TY - JOUR

T1 - Rationale and design of BISTRO

T2 - a randomized controlled trial to determine whether bioimpedance spectroscopyguided fluid management maintains residual kidney function in incident haemodialysis patients

AU - Davies, Simon J

AU - Caskey, Fergus J

AU - Coyle, David

AU - Lindley, Elizabeth

AU - MacDonald, Jamie

AU - Mitra, Sandip

AU - Wilkie, Martin

AU - Davenport, Andrew

AU - Farrington, Ken

AU - Dasgupta, Indranil

AU - Ormandy, Paula

AU - Andronis, Lazaros

AU - Solis-Trapala, Ivonne

AU - Sim, Julius

PY - 2017/4/26

Y1 - 2017/4/26

N2 - 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

AB - 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

KW - Fluid status

KW - Health Economics

KW - Body Composition

KW - Residual kidney function

KW - Haemodialysis

KW - bioimpedance

KW - Fluid management

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U2 - 10.1186/s12882-017-0554-1

DO - 10.1186/s12882-017-0554-1

M3 - Article (Academic Journal)

C2 - 28441936

SN - 1471-2369

VL - 18

JO - BMC Nephrology

JF - BMC Nephrology

M1 - 138

ER -

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

Abstract

Keywords

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