A study comparing a form of haemodialysis that filters and replaces high volumes of blood water during each treatment (high-volume haemodiafiltration) with a form of haemodialysis that doesn’t (high-flux haemodialysis)
| ISRCTN | ISRCTN10997319 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10997319 |
| IRAS number | 227067 |
| Secondary identifying numbers | CPMS 34704, IRAS 226067 |
- Submission date
- 02/10/2017
- Registration date
- 10/10/2017
- Last edited
- 16/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Urological and Genital Diseases
Plain English Summary
Background and study aims
Most people with kidney failure need blood cleaning treatment (haemodialysis) for four hours three times a week up at a hospital/clinic. This is for the rest of their life unless they are fit to receive a kidney transplant. Survival and quality of life on haemodialysis are poor. The addition of filtration (the removal and replacement of fluid) to regular haemodialysis (which allows toxins to leave the blood with minimal fluid removal/ replacement) is known as haemodiafiltration. The aim of this study is to see whether removing and replacing 21 or more litres of fluid from the blood at the time of a standard dialysis treatment reduces death or hospitalisation from cardiac events or infections in people with kidney failure. Effects on quality of life, admission to hospital, symptoms, infection rates and costs are also examined.
Who can participate?
Adults aged 18 and older who are receiving dialysis treatments three times a week.
What does the study involve?
This study will randomly allocate patients already on dialysis in one of 20 centres in the UK are randomly allocated to switch to either haemodialysis or haemodiafiltration. This does not noticeably change the dialysis procedure as far as the patient is concerned – it is still 4 hours 3 times a week – it just requires changes in equipment and nurse practice. It does however require a greater volume of high-quality water. A research nurse collects the initial clinical information. All follow-up is carried out using data already routinely collected by the UK Renal Registry or by linking with other health care databases. Quality of life information is collected. Interviews are carried out and conversations studied in the preparatory and recruitment stages of the study.
What are the possible benefits and risks of participating?
Participants may benefit haemodiafiltration may improve survival as it may remove toxins more effectively, especially if high volumes are used (i.e. more than 21L of water removed and replaced per session. On the downside, such volumes of filtration could remove essential proteins or introduce toxins or infections from the water supply. Therefore it is needed to establish if haemodiafiltration results in benefits to patients, is safe and justifies any additional financial and environmental (e.g. water) costs.
Where is the study run from?
This study is being run by the University of Bristol (UK) and takes place in different hospitals in the UK.
When is the study starting and how long is it expected to run for?
May 2017 to September 2025 (updated 20/08/2021, previously: March 2024)
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
1. Dr Sunita Procter
H4rt-study@bristol.ac.uk
2. Prof Fergus Caskey
Fergus.caskey@bristol.ac.uk
Contact information
Public
Population Health Sciences
Bristol Medical School
University of Bristol
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
 ORCID ID |
0000-0002-2174-600X |
|---|---|
| Phone | +44 (0)117 928 7286 |
| H4rt-study@bristol.ac.uk |
Scientific
Learning and Research
Southmead Hospital
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
| ORCID ID |
0000-0002-5199-3925 |
|---|---|
| Phone | +44 (0)117 414 8150 |
| Fergus.caskey@bristol.ac.uk |
Study information
| Study design | Randomized; Interventional; Design type: Treatment, Device, Complex Intervention |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The High-volume Haemodiafiltration vs High-flux Haemodialysis Registry Trial (H4RT) |
| Study acronym | H4RT |
| Study hypothesis | The aim is to establish the effectiveness and cost-effectiveness of high-volume HDF compared with high-flux HD in adult patients with ESKD on maintenance thrice weekly in-centre HD. This will be done by running a randomised controlled trial using non-cancer mortality or hospital admission due to a cardiovascular event or infection as our primary outcome. |
| Ethics approval(s) | South Central – Berkshire Research Ethics Committee, 07/09/2017, ref: 17/SC/0391 |
| Condition | Renal failure |
| Intervention | Participants in the intervention arm receive in-centre, high-volume, post-dilution HDF typically for four hours, three times a week. Participants in the control arm receive in-centre high-flux HD typically for four hours, three times a week. Participants in both arms are followed up for 32 months minimum (50 months maximum) using six monthly paper or electronic questionnaires. Follow up data are also accessed by linking to routine healthcare databases i.e. UK Renal Registry, Hospital Episode Statistics and Office for National Statistics data (and their equivalents in Wales, Scotland and Northern Ireland). |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Not provided at time of registration |
| Primary outcome measure | 1. Non-cancer mortality or hospital admission with a cardiovascular event or infection from randomisation to end of follow-up 2. A composite of first of non-cancer mortality or admission to hospital related to a cardiovascular event or infection is measured using datasets (UKRR, Hospital Statistics & ONS) from randomisation to end of follow-up (32-50 months depending on recruitment) |
| Secondary outcome measures | 1. All-cause mortality, cardiovascular and infection related morbidity and mortality. Health-related quality of life (QoL), cost effectiveness and environmental impact 2. All-cause mortality is measured using datasets (UKRR and ONS) from randomisation to end of follow-up (32-50 months depending on recruitment) 3. Cardiovascular – cause specific hospitalisation and mortality is measured using datasets ((UKRR, Hospital Statistics (HES, PEDW, ISD, NISRA) & ONS) from randomisation to end of follow-up (32-50 months depending on recruitment) 4. Infection – cause- specific hospitalisation and mortality using datasets (MRSA & MSSA) (Public Health England) from randomisation to end of follow-up (32-50 months depending on recruitment) 5. Health-related quality of life (QoL) – quality adjusted life years gained (EQ-5D-5L), generic quality of life (SF-36), disease specific (kidney symptoms within KDQOL-36) and time to recover after dialysis: From Patient Questionnaires - assessed using repeated measures taken six-monthly 6. Cost effectiveness and environmental impact (including locally purified water, manufactured saline and plastic consumables): using all available data for the full duration of follow-up (32-50 months) |
| Overall study start date | 01/05/2017 |
| Overall study end date | 30/09/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 1550; UK Sample Size: 1550 |
| Total final enrolment | 1553 |
| Participant inclusion criteria | 1. Adult patients aged 18 and older receiving in-centre, maintenance HD or HDF for ESKD 2. Dialysing three times a week in a main dialysis unit or satellite unit 3. Potential to achieve high-volume HDF |
| Participant exclusion criteria | 1. Lack of capacity to consent 2. Clinician predicted prognosis of less than 3 months 3. Started maintenance HD within the preceding 4 weeks 4. Transition to living kidney donor transplant or home dialysis scheduled within next 3 months 5. Not suitable for high-volume HDF for other clinical reasons such as dialysis less than thrice weekly or unlikely to achieve sufficient blood flow rates with current vascular access 6. Treatment with HDF for more than 3 months prior to inclusion in the trial or prior intolerance of HDF |
| Recruitment start date | 01/11/2017 |
| Recruitment end date | 08/09/2022 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
Southmead Road
Westbury-On-Trym
Bristol
BS10 5NB
United Kingdom
Trust Headquarters
Derby Road
Nottinghamshire
Nottingham
NG7 2UH
United Kingdom
Ipswich Suffolk
Ipswich
IP4 5PD
United Kingdom
Stott Lane
Salford Greater Manchester
Salford
M6 8HD
United Kingdom
Freeman Road
High Heaton
Newcastle-Upon-Tyne
NE7 7DN
United Kingdom
Edinburgh
EH16 4SA
United Kingdom
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
Staffordshire
Stoke-On-Trent
ST4 6QG
United Kingdom
Aberdeen
AB25 2ZN
United Kingdom
Glasgow
G51 4TF
United Kingdom
E1 1BB
United Kingdom
NW3 2QG
United Kingdom
NG5 1PB
United Kingdom
CV2 2DX
United Kingdom
SG1 4AB
United Kingdom
BD5 0NA
United Kingdom
TR1 3LQ
United Kingdom
M13 9WL
United Kingdom
CT1 3NG
United Kingdom
SE1 9RT
United Kingdom
LE5 4PW
United Kingdom
PL6 8DH
United Kingdom
SR4 7TP
United Kingdom
DD1 9SY
United Kingdom
KY2 5AH
United Kingdom
TS4 3BW
United Kingdom
S5 7AU
United Kingdom
PO6 3LY
United Kingdom
L7 8XP
United Kingdom
CO4 5JL
United Kingdom
Headington
Oxford
OX3 9DU
United Kingdom
Epsom
KT18 7EG
United Kingdom
London
SW17 0QT
United Kingdom
Lyndhurst Road
Worthing
BN11 2DH
United Kingdom
Sponsor information
Hospital/treatment centre
Southmead Hospital
Southmead Road
Westbury-On-Trym
Bristol
BS10 5NB
England
United Kingdom
"ROR" |
https://ror.org/036x6gt55 |
|---|
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 | 28/02/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Current publication and dissemination plan as of 16/12/2024: Academic publications will be targeted at high impact general medical journals with presentations at leading nephrology conferences. Findings will also be used to inform future iterations of the NICE-approved UK Renal Association clinical guidelines and the European Renal Best Practice clinical guidelines. _____ Previous publication and dissemination plan: Academic publications will be targeted at high impact general medical journals such as the BMJ, the New England Journal of Medicine and the Journal of the American Medical Association. Findings will be presented at leading nephrology conferences in Europe (the ERA-EDTA Annual Congress) and North America (The American Society of Nephrology Kidney Week) as well as at the UK Kidney Week, co-hosted by the Renal Association and the multi-disciplinary British Renal Society. Findings will also be used to inform future iterations of the NICE-approved UK Renal Association clinical guidelines and the European Renal Best Practice clinical guidelines. The H4RT protocol is available at reference URL: https://www.journalslibrary.nihr.ac.uk/programmes/hta/158052/#/ A statistical analysis plan approved by the trial steering committee will be made publicly available in due course. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 27/06/2022 | 28/06/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
16/12/2024: The following changes were made to the trial record:
1. The intention to publish date was changed from 30/09/2025 to 28/02/2026.
2. The publication and dissemination plan was changed.
02/11/2023: The IRAS number was added.
20/09/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/09/2022 to 08/09/2022.
2. The intention to publish date was changed from 31/03/2025 to 30/09/2025.
3. The total final enrolment was added.
28/06/2022: Publication reference added.
20/08/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/08/2021 to 30/09/2022.
2. The overall end date was changed from 31/03/2024 to 30/09/2025.
3. The trial participating centre Worthing Hospital was added.
4. The plain English summary was updated to reflect these changes.
23/02/2021: Acronym added to scientific title.
17/02/2021: Contact details updated.
15/02/2021: The following changes were made to the trial record:
1. Recruitment to this study is no longer paused.
2. The recruitment end date was changed from 31/03/2021 to 31/08/2021.
3. Oxford University Hospital, Epsom and St Helier University and St George's University Hospital were added as trial participating centres.
11/06/2020: The trial participating centres were updated to add the Royal London Hospital, Nottingham University Hospitals NHS Trust - City Campus, Royal Free Hospital, University Hospital Coventry, Lister Hospital, St Luke's Hospital, Royal Cornwall Hospital (Treliske), Manchester Royal Infirmary, Kent & Canterbury Hospital, Guy's and St Thomas' NHS Foundation Trust, Leicester General Hospital, Derriford Hospital, City Hospitals Sunderland, Ninewells Hospital, Victoria Hospital, The James Cook University Hospital, Sheffield Teaching Hospitals, Queen Alexandra Hospital, Royal Liverpool and Broadgreen University Hospital, Colchester General Hospital.
04/05/2020: Due to current public health guidance, recruitment for this study has been paused.
14/01/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2019 to 31/03/2021.
2. The overall end date was changed from 30/04/2022 to 31/03/2024.
3. The intention to publish date was changed from 30/04/2023 to 31/03/2025.
4. The plain English summary was updated to reflect these changes.
07/10/2019: The recruitment end date was changed from 30/09/2019 to 31/12/2019.
08/05/2019: The recruitment end date was changed from 30/04/2019 to 30/09/2019.
03/04/2019: The condition has been changed from "Specialty: Renal disorders, Primary sub-specialty: Renal disorders; UKCRC code/ Disease: Renal and Urogenital/ Renal failure" to "Renal failure" following a request from the NIHR.
26/10/2017: Internal review.
