About the study

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.

UK target: 516 incident haemodialysis patients

Number of sites required: 35 sites (estimate)

Minimum site target: 15 new haemodialysis patients recruited per site. However if a site is really interested and has an exceptional track record on delivery in renal trials, they should fill in the site feasibility form and a lower recruitment target would be considered on a case by case basis.

Study population: Incident haemodialysis patients with residual kidney function

Planned recruitment period: 06/04/2017 to 30/09/2019 

Planned end of follow up: 30/09/2020 

Primary objective: to demonstrate a clinically significant lengthening in time to anuria in those randomised to the BI intervention

Research grant provision to sites: Participating sites will require access to one or more Fresenius BCM machine(s). As BISTRO is funded by the NIHR HTA Programme grant, the purchase of the Fresenius BCM machine is considered a treatment cost. However BISTRO has agreed with Fresenius a discounted price for these.

BISTRO will provide FREE bespoke expert led training and technical support in making bioimpedance readings and interpretation for clinical assessments. 

 

Chief Investigator

Prof Simon Davies

Sponsor 

Keele University

Funder

NIHR Health Technology Assessment (HTA) Programme

HRA Project ID and Approval Date

206213, 4th Oct 2016

CPMS ID (NIHR UK Clinical Trials Gateway)

31766

Contact us

NSTCCG.BISTRO@nhs.net

Inclusion Criteria

- Adults aged >18 years commencing centre-based maintenance haemodialysis due to advanced kidney disease CKD stage 5, planned or unplanned, via arterio-venous fistula, graft or central venous catheter (i.e. with or without permanent vascular access)
 
- Commencing dialysis on any regimen, including having incremental dialysis initiation
 
- Residual kidney function:
      a) For patients who have not yet but are about to start dialysis treatment they should have a daily urine volume > 500ml/day and/or a measured mean urea and creatinine clearance ≥3ml/min/1.73m2 determined from a 24 hour collection;
      b) For patients already on dialysis they should have a urine volume >500ml during the short inter-dialytic period and/or a measured mean urea and creatinine clearance ≥3ml/min/1.73m2, determined from the same timed inter-dialytic urine collections and an average of the post- and pre-dialysis plasma urea and creatinine concentrations

Exclusion Criteria

- Unable or unwilling to give informed consent

- Unable to comply with trial procedures, e.g. collection of urine output

- Likely survival prognosis or planned modality transfer < 6 months

- Subjects with limb amputations when the foot is not accessible AND it is not possible to take hand to hand measurements