The BISTRO Trial
BioImpedance Spectroscopy To Maintain Renal Output
BISTRO is an NIHR HTA funded pragmatic, multicentre randomised controlled trial to determine if incorporation of bioimpedance into the setting of the post dialytic weight reduces loss of residual kidney function in incident centre-based HD patients, with the potential to improve clinical outcomes, in particular dialysis related symptoms, hospitalisation and survival.
|Cheif Investigator:||Professor Simon Davies|
|Trial Manager:||Dr Nancy Fernandes da Silva|
|Sponsor / Reference Number:||Keele University / RG_0012_16_IACS|
|Funder / Reference Number:||NIHR Health Technology Assessment (HTA) Programme / 14/216/01|
|UKCRN Study Portfolio Reference Number:||31766|
|Registration Reference Number:||ISRCTN11342007|
|Start Date:||01 Jun 2016|
|End Date:||31 Jan 2022|
This is a Pragmatic, Multicentre, Open-Label Prospective Randomised Controlled Trial.
To recruit 516 patients commencing HD to the trial, sufficient to demonstrate a clinically significant difference in time to anuria in those randomised to the Bioimpedance Spectroscopy (BI) intervention limb versus those randomised to the control limb.
To determine effect of intervention on:
- The rate of decline in kidney function
- Significant events, including vascular access failure and associated interventions, cardiovascular events, hospital admissions and deaths
- Dialysis efficacy and safety
- Patient reported outcomes, including quality of life dialysis-related symptoms, Integrated Palliative Care Outcome Scale- Renal, Patient Activation, Physical function, cognitive function
Cost-effectiveness of the intervention.