Most people with kidney failure receive blood cleaning treatment (haemodialysis) 3 times a week at a hospital/ clinic.

By adding filtration (the removal and replacement of fluid) to regular haemodialysis (which allows toxins to leave the blood with minimal fluid removal/ replacement) we get haemodiafiltration. As far as you, the patient, are concerned the two procedures are very similar – they both involve about 4 hours treatment 3 times a week, the dialysis machine is just set up slightly differently. Haemodiafiltration does, however, require a greater volume of high quality water. By removing toxins more effectively, haemodiafiltration should in theory have benefits, especially if high volumes are used (i.e. more than 21L of water removed and replaced per dialysis session). On the downside, such volumes of filtration could remove essential proteins from your blood stream.

This trial aims to see whether there is any difference between high-volume haemodiafiltration and high-flux haemodialysis in terms of longer term survival and hospitalisation from heart disease or infections in people with kidney failure. Effects on quality of life, admission to hospital, symptoms, infection rates and costs will also be examined.

A secondary aim is to understand how people make decisions about participating in clinical studies like H4RT. Currently we know little about how people make decisions about whether or not to take part in clinical studies. One way to improve our knowledge is to audio-record the conversations you have with hospital staff about your possible participation in the H4RT study. This will help us to understand better how the information about the H4RT study is presented to you, and how we could improve the way we discuss the study with patients in the future.  Interviewing you after you have made your decision about whether or not to take part in H4RT will also help us to understand how you came to your decision.

• Research has shown no benefit of haemodiafiltration over haemodialysis, but it has not previously looked at using high volumes of fluid removal/ replacement.
• Kidney specialists therefore don’t know which treatment is best for which patient.
• Reflecting this, whether you get high-volume haemodiafiltration or high-flux haemodialysis today in the UK depends largely on which renal unit you go to.
• We want to find the best treatment for people with kidney disease.
• If you agree to take part in the study:
  • You will continue to be looked after by the same team of NHS doctors and nurses that you see at the moment.
  • You should not notice any difference in the dialysis treatment you receive. In particular, you should not spend any longer time on dialysis than you would if you were not in the study.
  • There will be no extra clinic visits or blood tests.

You can discontinue with the study at any time and for any reason. If you decide to discontinue with the study you will return to usual care at your renal unit, which could involve either haemodialysis or haemodiafiltration. You do not have to tell us why you want to discontinue with the study. 

You are being invited to take part in this study because you have been attending a dialysis unit three times a week for at least 4 weeks and have a fistula, graft or tunnelled line that is working well. You therefore appear suitable for either:

• High-volume haemodiafiltration, three times a week
• High-flux haemodialysis, three times a week

Do I have to take part?

Participating in this study is completely voluntary. You are free to change your mind and leave the study at any time without giving a reason. If you choose not to take part, or if you leave the study, your future medical treatment and normal standard of care will not be affected in any way. Taking part in this study will not affect your employment in any way.

What will happen if I take part?

If you agree to take part in the study you will be asked to provide a 24 hour urine sample and bring to your appointment and to sign a study consent form. Then one of the research nurses will ask you some questions about your health and do a simple physical assessment. You will be asked to complete a questionnaire designed to measure your health, quality of life and symptoms of kidney disease. This assessment should take no more than 60 minutes.

Once this has happened, the research nurse will contact the clinical trials unit and find out whether you have been allocated to (a) high-volume haemodiafiltration or (b) high-flux haemodialysis. Neither you nor the clinical team involved in your care will choose which treatment you receive. Instead, the treatment you receive will be allocated at random, through a process called ‘randomisation’. This means that you will have an equal chance of receiving either treatment.

The clinical team involved in your care are confident that both of these treatments are appropriate for you. They agree that we do not currently know if one treatment is better, or if they are both the same. By doing this clinical study, we hope to find out the advantages and disadvantages of the treatments and if one is better than the other.

The allocation process (randomisation) should take no more than 5 minutes and in most situations the result will be given to you straight away.

If you are randomly allocated to high-volume haemodiafiltration

• The nurses in your dialysis unit will then change the way they programme your machine to add the filtration component.
• Over the next few weeks and months they will monitor how much filtration the dialysis machine is managing to achieve, aiming for 23 litres or more at each session.
• The programme on your dialysis machine will be gradually altered to achieve this amount of filtration, for example by changing the dialyser or increasing the blood flow and the percentage of the blood that is filtered.

If you are randomly allocated to high-flux haemodialysis

• The nurses will continue to set up and programme your machine for high-flux haemodialysis.
• Over the next few weeks and months they will monitor how much haemodialysis the dialysis machine is managing to provide, ensuring that you receive the recommended amount.
• The programme on your dialysis machine will be gradually altered to achieve this amount of haemodialysis, for example by changing the dialyser or increasing the blood flow.
• After the initial study visit, there will be no further visits from the research nurse. Every six months for up to 4 years you will receive a questionnaire through the post. By filling this in you will give us an update about how your health has been over that year.
• We will also ask your permission to access your healthcare notes kept by the hospital so that we can find out about aspects of the care of your kidney disease, and other medical problems that may affect your health.
• Lastly, we will ask your permission to access data about your health from other organisations (explained in detail below in the section called “Collecting data about you from other healthcare organisations”).

What happens at the research visits?

• After the initial study visit, there will be no further visits from the research nurse. Every six months for up to 4 years you will receive a questionnaire through the post. By filling this in you will give us an update about how your health has been over that year.
• We will also ask your permission to access your healthcare notes kept by the hospital so that we can find out about aspects of the care of your kidney disease, and other medical problems that may affect your health.
• Lastly, we will ask your permission to access data about your health from other organisations (explained in detail below in the section called “Collecting data about you from other healthcare organisations”). 

What happens if I become unable to make treatment decisions?

Any of us can lose the ability to make decisions about the treatments we receive at any time. If this happens to you while you are taking part in the study you will have to leave the study and return to usual care in your dialysis unit.

In all situations, unless you request otherwise, the study team would keep the personal data already collected and continue to use it according to the consent you previously gave for the study.

There is no guarantee that you will benefit from taking part in this study. The treatment you receive as part of the study may lead to an improvement in your symptoms and general health, but we cannot predict whether this will be the case. However information collected during this study may benefit patients like you with kidney disease in the future.

What are the possible disadvantages of taking part?

Both treatments in H4RT are currently being offered as standard care in many renal units around the country. Like any treatments provided on the NHS, both treatments have potential disadvantages and risks. If you are allocated to haemodiafiltration, there is a possibility that this could remove essential proteins from your blood. Both treatments may introduce toxins or infections from the water supply, though this risk is slightly higher for high-volume haemodiafiltration.

Although there are possible advantages and disadvantages to both treatments, the doctors involved in your care believe both treatments are safe, suitable options for you. Your specialist kidney team are happy for you to take part in this research. However, the study will take up some of your time, as explained above. 

At the end of the study your NHS specialist kidney team will discuss with you the current treatment options in terms of haemodialysis and haemodiafiltration. It will be up to you and your NHS specialist kidney team to decide whether you should continue on your allocated treatment or change to something else. You will have no further contact with the research team, but with your permission information will continue to be collected for another 5 years from the organisations listed in Part 3. This will allow longer term effects can be studied. 

If you are not satisfied with the treatment you have been allocated to at any time then you can stop taking part in the trial and go back to the usual care at your dialysis unit. You can withdraw from the study at any time and without giving a reason.

You can withdraw by telephoning the research nurse (for details see later in this leaflet) or by writing to the coordinating centre (for details see www.bristol.ac.uk/population-health-sciences/projects/h4rt-trial/). This will allow us to discuss your concerns with you and determine what you want to happen next from the following options.

• “No further contact”: This means that the H4RT research team will no longer contact you directly, but still have your permission to retain and use information provided previously and to obtain and use further information from your health records.
• “No further use”: This means that, in addition to no longer contacting you or obtaining further information about you, any information collected previously would no longer be available to researchers.  You can also request that any data collected on you for the study is destroyed.

If, having discussed your concerns and the options, you do decide to withdraw from the trial the nurse will fill in a form to confirm this.

The results from this trial will tell us whether high-flux haemodialysis or high-volume haemodiafiltration gives the better results. Nephrologists will be informed of the recommendations from the study, so that in future all patients can receive the best information before deciding what treatment to have.

The results of this study will be published in scientific journals. No one will be able to identify you from any of the study reports.

This study is being funded by the National Institute for Health Research (NIHR) Health Technology Assessment Programme (HTA) (project number 15/80/52). The research is being carried out by a group of experienced doctors and researchers at each of the hospitals involved in this study. They are working in collaboration with researchers at the University of Bristol’s Bristol Randomised Trials Collaboration (BRTC), a fully registered Clinical Trials Unit. The study is sponsored by North Bristol NHS Trust.

South Central - Berkshire Research Ethics Committee, your local hospital and your kidney consultant have given approval for this study to be carried out. An independent Trial Steering Committee and a Data Monitoring Committee monitor safety and ensure that the study is carried out in accordance with good research practice.

We will ask your permission to access your healthcare notes kept by the hospital so that we can find out about aspects of the care of your kidney disease, and other medical problems that may affect your health. We will also ask your permission to access data that have been collected about you during routine appointments and hospital visits by the organisations described at the end of the patient information sheet. This is important as it cuts down how much work you have to do telling us about your health and avoids extra blood tests. Also, it will make it possible to collect some information about you after the trial has finished. Lastly, it will mean that if you do not continue with the trial or the questionnaires, and you give us permission, we can still collect some information about your health. 

In order to identify and obtain information about you, we will send information that identifies you (such as your name, address, gender, date of birth, and NHS number) to the organisations listed in Part 3 of this information sheet.  They will then attach the relevant health information about you and return the data to us. All data transfers involving identifiable information will be done securely using data encryption and keeping identifiable information to a minimum.

All information collected about you as a result of your participation in the study will be used for the purposes of this research only. Your personal and medical information will be kept in a highly secure server within the University of Bristol or the UK Renal Registry and handled in the strictest confidence (in accordance with data protection law).  You may ask to see your personal information at any time and correct any errors if necessary. We will need to inform your GP that you are taking part in this study so that they take this into account when making any decisions about your care.

Once you have agreed to participate in this study you will be allocated a unique study number which will be used on all your study documentation.  This number will be linked to your personal information, but you will only be identified by this unique number in the final study data. Your consent to the use of your study data or your personal data does not have a specific expiry date, but you may withdraw your consent at any time by notifying your study doctor. Although the study only lasts for 5 years, unless otherwise instructed by you, we will retain your data for 15 years. This is considered best practice for clinical trials. The data will then be securely destroyed.

By giving informed consent, you consent to the study doctor and their staff collecting and using medical and personal data about you for the purposes of the study (study data). This includes: your name, address, date of birth, gender, your ethnic origin and personal data about your physical or mental health or condition. Authorised staff working for the sponsor of the study or the hospital Research and Development Department may require access to your personal information and/or medical records to check the data for this study and ensure that it is being conducted according to international best practice guidance.  All information will be treated in the strictest confidence during the review process.

By participating in this study, you agree for the research team to follow your medical status on an on-going basis for the five year duration of the study and for five years beyond the end of the study. This involves collecting, processing, and transferring your personal data (name, address, gender, date of birth and NHS number) for medical research purposes only. This will be done by sending the named information to the health records organisations mentioned in Part 3 of this information sheet. For this process to work, some of your personal data will need to be stored on a secure, password-controlled database with access given to only a very small number of individuals delegated responsibility by the sponsor. The various organisations’ systems will be asked for information which will then be stored in our highly secure database. In addition, in order to send out your follow-up questionnaires, your study doctor will need to provide the coordinating study centre (Bristol Randomised Trials Collaboration at the University of Bristol) with some of your contact details.

No information from which you can be identified will be shared with researchers other than the study team and the organisations listed in Part 3. At the end of the study, anonymised study data may be shared with other researchers outside the University of Bristol, both in the United Kingdom and abroad. 

If there is negligent harm during the trial when the NHS body owes a duty of care to the person harmed, NHS indemnity covers NHS staff, medical academic staff with honorary contracts and those conducting the study. NHS indemnity does not cover no-fault compensation and is unable to agree in advance to pay compensation for non-negligent harm.

If you have any questions about the study, or any aspect of your treatment or health whilst on the study, please ask to speak to the H4RT research nurse or consultant.

1. UK Renal Registry – all kidney units in the UK send information about their patients to the UK Renal Registry. This is to make sure that patients receive good quality care. As part of this, aspects of your treatment, your blood test results and information that could identify you (such as study number, NHS number, date of birth and gender) are routinely sent to the UK Renal Registry. If you agree to take part in the study, you will be agreeing that we can use this information from the UK Renal Registry to find out what happens to your health during the study.

2. NHS Digital stores and analyses information from healthcare organisations in England and Wales. If you take part in the study, we will send information that identifies you (study number, NHS number, date of birth and gender) to NHS Digital. They maintain two databases called HES (Hospital Episode Statistics) and ONS (Office for National Statistics). If they have records about you on either of these databases, they will send back identifiable information (study number) along with dates and details for hospital admission/ attendance and date and cause of death.

3. Hospital Episode Statistics – The NHS collects Hospital Episode Statistics information on all hospital admissions/ attendances, including when, why and for how long they happen. By collecting information from HES, we can tell what happens to a participant’s health during the study. For example, if someone is admitted to hospital this will be recorded. By doing this, it means that we can use the information the NHS already collects rather than do regular extra study visits. This is particularly important for people with other health problems as treatment already takes up a lot of time.

4. Office for National Statistics – When someone dies in England, this is recorded in civil registration data. This includes the date and cause of death. The Office for National Statistics can make these data available for research through NHS Digital. As well as providing information about date and cause of death, this reduces the chances of us sending mail, messages or calls to patients who are no longer alive, which might upset relatives or friends.

By consenting to this study, you agree that the study team will provide your details to NHS Digital for linkage to HES and ONS data. 

1. UK Renal Registry – all kidney units in the UK send information about their patients to the UK Renal Registry. This is to make sure that patients receive good quality care. As part of this, aspects of your treatment, your blood test results and information that could identify you (such as study number, NHS number, date of birth and gender) are routinely sent to the UK Renal Registry. If you agree to take part in the study, you will be agreeing that we can use this information from the UK Renal Registry to find out what happens to your health during the study.

2. The Information Services Division (ISD) of NHS Scotland collects, stores and analyses healthcare information about people living in Scotland. If you take part in the study, we will send information that identifies you (study number, Community Health Index number, date of birth and gender) to ISD. They will link this information to their databases to find information about you. If you have been admitted to hospital they will send back identifiable information (study number) along with the date and cause of hospital admission. The NHS collects information on all hospital admissions/ attendances, including when, why and for how long they happen. By using this information, we can tell what happens to a participant’s health during the study. For example, if someone is admitted to hospital this will be recorded. By doing this, it means that we can use the information the NHS already collects rather than do regular extra study visits. This is particularly important for people with other health problems as treatment already takes up a lot of time.

3. National Records for Scotland (NRS) – When someone dies in Scotland, this is recorded in civil registration data. The National Records for Scotland can make these data available for research. As part of this study, we will send the National Records for Scotland enough information to be able to identify people in this study (study number, Community Health Index number, date of birth and gender) and if someone has died they will send back identifiable information (study number) along with the date and cause of death. This reduces the chance of us sending mail, messages or calls to patients who are no longer alive, which might upset relatives or friends.

By consenting to this study, you agree that the study team will provide your details to ISD and NRS for linkage to their databases. 

1. UK Renal Registry – all kidney units in the UK send information about their patients to the UK Renal Registry. This is to make sure that patients receive good quality care. As part of this, aspects of your treatment, your blood test results and information that could identify you (such as study number, NHS number, date of birth and gender) are routinely sent to the UK Renal Registry. If you agree to take part in the study, you will be agreeing that we can use this information from the UK Renal Registry to find out what happens to your health during the study.

2. Patient Episode Database for Wales (PEDW) – The NHS in Wales collects information on all hospital admissions/ attendances, including when, why and for how long they happen. This is known as Patient Episode Database for Wales and is managed by an organisation called the NHS Wales Informatics Service. As part of this study, we will send PEDW enough information to be able to identify people in this study (study number, NHS number, date of birth and gender) and if someone has been admitted to/ attended hospital they will send back identifiable information (study number) along with details of the hospital admission/ attendance. By collecting information from PEDW, we can tell what happens to a participant’s health during the study. For example, if someone is admitted to hospital this will be recorded. By doing this, it means that we can use the information the NHS already collects rather than do regular extra study visits. This is particularly important for people with other health problems as treatment already takes up a lot of time.

3. Office for National Statistics – When someone dies in Wales, this is recorded in civil registration data. The Office for National Statistics can make these data available for research through NHS Digital. As part of this study, we will send NHS Digital enough information to be able to identify people in this study (study number, NHS number, date of birth and gender) and if someone has died they will send back identifiable information (study number) along with the date and cause of death. This reduces the chances of us sending mail, messages or calls to patients who are no longer alive, which might upset relatives or friends.

By consenting to this study, you agree that the study team will provide your details to NHS Digital and NHS Wales Informatics Service for linkage to ONS and PEDW data. 

1. UK Renal Registry – all kidney units in the UK send information about their patients to the UK Renal Registry. This is to make sure that patients receive good quality care. As part of this, aspects of your treatment, your blood test results and information that could identify you (such as study number, NHS number, date of birth and gender) are routinely sent to the UK Renal Registry. If you agree to take part in the study, you will be agreeing that we can use this information from the UK Renal Registry to find out what happens to your health during the study.

2. Department of Health Hospital Information Branch (DoH HIB) collects, stores and analyses information from healthcare organisations in Northern Ireland. As part of this study, we will send DoH enough information to be able to identify people in this study (study number, Health and Care Number, date of birth and gender) and if someone has been admitted to/ attended hospital they will send back identifiable information (study number) along with details of the hospital admission/ attendance.  By accessing this information we can tell what happens to a participant’s health during the study. For example, if someone is admitted to hospital this will be recorded. By doing this, it means that we can use the information the NHS already collects rather than do regular extra study visits. This is particularly important for people with other health problems as treatment already takes up a lot of time.

3. Northern Ireland Statistics and Research Agency (NISRA) – When someone dies in Northern Ireland, this is recorded in civil registration data. The NISRA can make these data available for research. As part of this study, we will send NISRA enough information to be able to identify people in this study (study number, Health and Care number, date of birth and gender) and if someone has died they will send back identifiable information (study number) along with the date and cause of death. This reduces the chances of us sending mail, messages or calls to patients who are no longer alive, which might upset relatives or friends.

    

By consenting to this study, you agree that the study team will provide your details to DoH and the NISRA for linkage to their databases.  

North Bristol NHS Trust is the sponsor for this study based in United Kingdom. We will be using information from you and/or your medical records in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. Bristol Randomised Trials Collaboration (University of Bristol), who manage the study on behalf of North Bristol NHS Trust will keep identifiable information about you for 15 years after the study has finished/ until 2037.

Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.

You can find out more about how we use your information at: www.nbt.nhs.uk/research-innovation/our-research/patient-information-health-care-research and/or by contacting: h4rt-study@bristol.ac.uk. 

Your NHS site will collect information from you and/or your medical records for this research study in accordance with our instructions.

Your NHS site will use your name, NHS number and contact details to contact you about the research study, and make sure that relevant information about the study is recorded for your care, and to oversee the quality of the study. Individuals from North Bristol NHS Trust, Bristol Randomised Trials Collaboration and regulatory organisations may look at your medical and research records to check the accuracy of the research study. Your NHS site will pass these details to Bristol Randomised Trials Collaboration along with the information collected from you and/or your medical records. The only people in North Bristol NHS Trust and Bristol Randomised Trials Collaboration who will have access to information that identifies you will be people who need to contact you to audit the data collection process. The people who analyse the information will not be able to identify you and will not be able to find out your name, NHS number or contact details.

Your NHS site will keep identifiable information about you from this study for 15 years after the study has finished/ until 2037.