Recipient organisationKeele UniversitySource-published name: University of Keele
Funding£1.3M
PeriodJun 2016 — Jul 2023
In plain English
AI plain-English summary
A simple electrical scan could help thousands of kidney dialysis patients hold onto their remaining kidney function for longer. The BISTRO trial is testing whether bioimpedance spectroscopy—a quick, painless measurement of body fluid levels—can help clinicians set more accurate fluid removal targets during dialysis, preventing the dangerous dehydration that often accelerates kidney failure. Current practice relies on clinical judgment alone, which frequently overshoots, damaging residual kidney function and hastening the need for total fluid removal. If successful, this approach would give patients more months or years of partial kidney function, reducing dialysis-related symptoms, hospitalisations, and the crushing fatigue that follows treatment. The trial follows over five hundred new dialysis patients across UK units, tracking whether guided fluid management delays the point at which urine output drops below a clinically negligible level. For the NHS, preserving residual kidney function means fewer complications, lower costs, and better quality of life for a growing population dependent on life-sustaining dialysis.
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DESIGN: Pragmatic, multicentre, open-label prospective randomised controlled trial comparing current best practice in setting the post-dialytic target weight with the same guided by serial BI measurements. BI readings will be taken in both study groups but concealed from the clinical team in the controls. SETTING: Adult outpatient haemodialysis units (main and satellite) and renal ward during hospital admission. TARGET POPULATION: Adults >18 years commencing out-patient maintenance haemodialysis, planned/unplanned, with or without permanent access, including incremental initiation INCLUSIONS - Residual kidney function: >500 ml for the short interdialytic gap and/or a measured mean urea and creatinine clearance > 3ml/min/1.73m2 EXCLUSIONS -Unable/unwilling to give informed consent -Unable to comply with trial procedures. -Likely survival prognosis or planned modality transfer <3 months. -Subjects with amputations (this will depend on the level of lower limb loss), pregnancy PRIMARY OUTCOME: time to anuria, <100 ml/day or 200 ml in the short interdialytic period confirmed by a further collection after 2 weeks to exclude temporary illness. SECONDARY OUTCOMES - Slope of decline of residual renal solute clearance. - Patient-centred outcomes: Dialysis-related symptoms; Intra-dialytic hypotension; Post-dialysis recovery time; Falls; Inter-dialytic weight gain; Physical function (Duke ASI); Patient Activation Measure; and QOL as required for the economic evaluation -Significant Events: hospitalisations, interventions, deaths. -Body composition/nutrition (BI derived) -Health economics outcomes SAMPLE SIZE Assuming a cumulative incidence of anuria of 30% in the control group and 20% in the treatment group, accounting for 11% competing risks (death, transplantation) – given exponential decline, proportional hazards, 90% power and 5% two-tailed significance - 185 events are required. Allowing for 5% loss to follow-up this requires 516 patients to be randomised 1:1. For the secondary outcome of rate of decline in renal clearance, at the same significance level this sample size would provide at least 90% power to detect a difference in rate of 0.05 ml/min/1.73m2/month, assuming linear change, assessments at 0, 1, 2, 3, 5, 7, 9, 11 and 13 months, and a (conservative)autocorrelation of 0.30. ANALYSIS Time to anuria will be analysed using competing risks survival analysis to estimate the relative risk (as expressed by the sub-hazard ratio) of the outcome (anuria) in patients where BI is used compared to control patients, accounting for the competing risks (death, transplantation). The analysis will control for known covariates affecting residual function, e.g. comorbidity, antihypertensive and diuretic use. Difference in rate of decline in renal clearance will be analysed using a random slopes linear mixed model. Corresponding appropriate analyses will be used for the other secondary outcomes. Pre-specified subgroup analyses will be limited to comorbid conditions that affect management of fluid status e.g. heart failure. For the economic evaluation base-case analysis will adopt the perspective of the NHS and personal social services with additional analyses undertaken from a wider societal perspective. Results will be presented as cost per additional QALY and plotted as cost-effectiveness acceptability curves.
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