Bio-impedance spectroscopy to maintain renal output
| ISRCTN | ISRCTN11342007 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11342007 |
- Submission date
- 25/04/2016
- Registration date
- 26/04/2016
- Last edited
- 24/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Most patients who develop kidney failure choose unit-based haemodialysis treatment. One of the main functions of dialysis is to control the amount of fluid in the body. Too much fluid can lead to persistently raised blood pressure that damages he heart and increases the risk of stroke, and may cause fluid to collect in the lungs leading to breathing difficulties which if allowed to get out of control could result in death. Too little fluid causes dehydration, cramps and low blood pressure on dialysis and more rapid or complete loss of any remaining kidney function along with its associated benefits. Bioimpedance is a simple, bedside measurement giving information about body composition, in particular how much excess fluid is present. Clinicians can use this to guide how much fluid should be removed from the body in conjunction with the normal clinical assessment of the amount of fluid in the body, but it is not known if this results in better decisions and outcomes for patients. The bioimpedance information can be shared with patients to help them understand the objectives of their treatment, potentially improving confidence in how their dialysis care is managed. The research is to test whether taking regular measurements with a bioimpedance device improves outcomes for people who have recently started haemodialysis treatment for kidney failure. In particular, the study aims to see if this helps patients maintain their remaining kidney function, as this is associated with improved survival, fewer symptoms of kidney failure, fewer side effects of dialysis treatment and a better quality of life including confidence in managing their health, and cost benefit analysis.
Who can participate?
Adults (aged at least 18) starting kidney dialysis due to advanced kidney disease.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in group 1 are regularly assessed with a bioimpedance device as well as receiving standard treatment. Those in group 2 receive standard treatment only. All participants are assessed at the start of the study, then once a month for three months. Assessments then continue every other month for up to the next 20 months. These assessments compare between the two treatments how quickly kidney function is declining, the side effects of treatment, symptoms of kidney failure, blood pressure and heart function, how confident the patient feels regarding managing their own health and the costs involved.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Keele University Clinical Trials Unit (UK)
When is the study starting and how long is it expected to run for?
June 2016 to July 2023
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Prof. Simon Davies
NSTCCG.BISTRO@nhs.net
Contact information
Scientific
Kidney Unit, Royal Stoke University Hospital
University Hospital of North Midlands NHS Trust
Newcastle Rd
Stoke-on-Trent, Staffordshire
ST4 6QG
United Kingdom
| Phone | +44 (0)1782 676346 |
|---|---|
| NSTCCG.BISTRO@nhs.net |
Study information
| Study design | Pragmatic multi-centre open-label prospective randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | https://www.keele.ac.uk/bistro/ |
| Scientific title | Bio-Impedance Spectroscopy To maintain Renal Output: a randomised controlled trial |
| Study acronym | BISTRO |
| Study objectives | The aim of the research is 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. |
| Ethics approval(s) | North of Scotland REC 2, 12/09/2016, ref: 16/NS/0094 |
| Health condition(s) or problem(s) studied | Urological and Genital Diseases |
| Intervention | Patients starting haemodialysis as an outpatient who still have some remaining kidney function will be invited to participate in a clinical trial that compares current best practice with the same but additionally guided by regular bioimpedance measurements. The trial will randomly assign, 516 patients from 30 dialysis units across the UK. The random allocation will be 1:1 to the Bioimpedance intervention and control groups, stratified by centre (main or satellite centre, where dialysis will commence) and planned versus unplanned start. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | - |
| Primary outcome measure | Time to anuria ( loss of urine output), <100ml/day or 200ml in the short inter-dialytic period confirmed by a further collection after 2 weeks to exclude temporary illness. To measure the primary outcome urine volume and residual renal clearances to be measured at baseline, monthly for 3 months and alternate months (for up to a further 20 months) until trial completion, or the primary endpoint is reached. |
| Secondary outcome measures | Determining the effect of the use of bioimpedance in assessing the amount of fluid in the body to guide the setting of the post-dialytic target weight on: 1. The rate that kidney function reduces ( baseline, monthly for 3 months, then alternate months for up to 20 months) 2. Vascular access failure, cardiovascular events, hospital admissions, death and including the use of routinely collected data from the UK Renal Registry, Hospital episode Statistics and the Office for National Statistics (and equivalent bodies in Wales, Scotland and Northern Ireland) via the UK Renal Registry. These are measured at baseline, and at the end of the study, routine clinical data collected by dialysis units for the UK Renal Registry returns will be made available for this study. Death will be recorded in real time during the study 3. Measures of dialysis efficacy and safety (body fluid assessment, blood pressure). These are measured at baseline, monthly for 3 months, then every 3 months for up to a further 20 months 4. Patient reported outcomes including quality of life, dialysis symptoms, functional status. These are measured at baseline, then 3 monthly for up to 24 months |
| Overall study start date | 01/06/2016 |
| Completion date | 31/07/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 516 patients will be included in total |
| Total final enrolment | 438 |
| Key inclusion criteria | 1. 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) 2. Commencing dialysis on any regimen, including having incremental dialysis initiation 3. Residual kidney function: For patients who have not yet started dialysis treatment they should have a daily urine volume > 500ml/day and/or a or a measured mean urea and creatinine clearance >3ml/min/1.72m2 determined from a 24 hour collection; 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/1.72m2, determined from the same timed inter-dialytic urine collections and an average of the post- and pre-dialysis plasma urea and creatinine concentrations. |
| Key exclusion criteria | 1. Unable or unwilling to give informed consent 2. Unable to comply with trial procedures, e.g. collection of urine output 3. Likely survival prognosis or planned modality transfer < 6 months 4. Subjects with limb amputations when the foot is not accessible AND it is not possible to take hand to hand measurements |
| Date of first enrolment | 17/04/2017 |
| Date of final enrolment | 30/09/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Arthritis Research UK Primary Care Centre
Research Institute for Primary Care Sciences
Staffordshire
ST5 5BG
United Kingdom
Sponsor information
University/education
Directorate of Engagement and Partnerships
IC2 Keele University Science and Innovation Park
Keele University
Keele, Staffordshire
ST5 5NH
England
United Kingdom
| Phone | +44 (0)1782 733374 |
|---|---|
| research.governance@keele.ac.uk | |
| Website | https://www.keele.ac.uk/researchsupport |
"ROR" |
https://ror.org/00340yn33 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The following outputs are planned: 1. Publication of the trial protocol (in an open access journal to coincide with the start of the trial). 2. Efficacy of the intervention, to include primary and selected secondary endpoints, especially dialysis related efficacy, safety and significant events. 3. Economic evaluation of the intervention and analysis of the benefits of residual kidney function. 4. In-depth analysis of effect of the intervention on the patient activation and engagement with fluid management 5. The impact of dialysis unit practice patterns on primary and secondary endpoints. 6. Publication of the clinically validated fluid assessment tool and associated educational material, with the potential develop this into an application suitable for hand-held devices The dissemination plan will be developed in close collaboration with the study oversight committee (Advisory and Dissemination Board facilitated by Kidney Research UK on behalf of the UK Kidney Research Consortium) and the steering group. Routes of dissemination will be as follows: National Meetings (to include study updates and findings): Renal Association and British Renal Society (e.g. annual Kidney Week, usually multidisciplinary meeting covering all aspects of nephrology and dialysis treatment). International Meetings (via submitted abstracts): American Society of Nephrology, European Dialysis and Transplantation Association/European Renal Association, European Dialysis and Transplantation Nurses Association, International Society of Nephrology. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Simon Davies (use both email addresses: medicine.datasharing@keele.ac.uk and s.j.davies@keele.ac.uk). Type of data: electronic deidentified trial data are available for request in aggregated format or at the level of the individual participant. Data availability: data will become available from Summer 2024 until 2031. Access criteria data: a data request form is required to be completed and must outline the type of data to be obtained, the reason for obtaining this data (research question/objective), the timing for when the data is required to be available (start date/end date). Checks will be performed by a Data Custodian and Academic Proposals (DCAP) committee at Keele to ensure that the data set requested is appropriately suited to answer the research question/objective and that the request fits with the original ethical approval and participant consent and adheres to funder and legal restrictions. Additional information: following an application by researchers who can demonstrate the capacity to undertake their pre-specified data analysis for what types of analyses; inclusion of data in participant level of summary-level meta-analyses; analyses of secondary outcomes not already undertaken by the research team and by what mechanism; formal application whether consent from participants was obtained; this was obtained, comments on data anonymisation; data will be in a fully anonymised format. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 26/04/2017 | Yes | No | |
| HRA research summary | 20/09/2023 | No | No | ||
| Results article | 30/05/2023 | 24/07/2024 | Yes | No | |
| Statistical Analysis Plan | version 3 | 06/07/2021 | 24/07/2024 | No | No |
Additional files
Editorial Notes
24/07/2024: Publication reference and statistical analysis plan added.
20/09/2023: A link to the HRA research summary was added.
31/01/2023: The following changes were made to the trial record:
1. The overall trial end date was changed from 31/12/2022 to 31/07/2023.
2. The intention to publish date was changed from 31/01/2023 to 31/12/2023.
01/02/2022: The overall trial end date was changed from 31/01/2022 to 31/12/2022.
06/07/2021: The intention to publish date has been changed from 30/04/2022 to 31/01/2023.
05/07/2021: The overall trial end date has been changed from 30/06/2021 to 31/01/2022 and the plain English summary updated accordingly.
22/02/2021: IPD sharing statement contact details updated.
26/01/2021: IPD sharing statement added.
14/01/2021: The following changes were made to the trial record:
1. The overall trial end date was changed from 31/01/2021 to 30/06/2021.
2. The intention to publish date was changed from 30/04/2021 to 30/04/2022.
01/07/2019: The following changes were made:
1. The recruitment end date was changed from 30/06/2019 to 30/09/2019.
2. The intention to publish date was changed from 31/01/2021 to 30/04/2021.
29/03/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 16/04/2018 to 30/06/2019.
2. The overall trial end date was changed from 31/07/2018 to 31/01/2021.
3. The intention to publish date was changed from 28/02/2020 to 31/01/2021.
4. Protocol number has been updated to version 3, 15/12/2017.
04/09/2017: Ethics approval has been added. Protocol number has been updated to version 2.0. Trial website has been added.
27/04/2017: Publication reference added.
27/03/2017: The recruitment dates have been updated from 01/03/2017 - 30/03/2018 to 17/04/2017 - 16/04/2018.
20/12/2016: The recruitment dates have been updated from 02/01/2017 - 02/01/2018 to 01/03/2017 - 30/03/2018. In addition, the trial website and sponsor website have been added.
