RecruitingOBSERVATIONAL

Adequacy of Haemodiafiltration: Middle Molecules Clearance, Patients Reported Outcomes and Sodium Balance

This study aims to understand how two types of kidney dialysis, haemodialysis and haemodiafiltration (HDF), affect patients. Researchers are looking at how well these treatments remove 'middle molecules' – waste products that are larger than urea, which standard dialysis often misses. They want to see if a higher volume of filtered fluid during HDF (above 23 litres) makes a difference to how patients feel and their overall health, compared to a lower volume. The study also investigates how different salt levels in the dialysis fluid might impact how much fluid builds up in a patient's body. The goal is to find better ways to measure how effective dialysis is, beyond just looking at urea removal, by considering overall well-being and managing fluid.

At a glance

Status

Recruiting

Sponsor

East and North Hertfordshire NHS Trust

Enrolment target

300

Start

09 Jan 2025

Estimated completion

01 Nov 2030

Haemodiafiltration Haemodialysis Patient Reported Outcome Measurements Nutrition Malnutrition (Calorie)Fluid Balance Outcomes

What is this study about?

This research is looking into how effective different types of kidney dialysis are, especially haemodiafiltration (HDF). If your kidneys don't work properly, dialysis helps clean your blood, removing waste products and extra fluid. For a long time, doctors mainly looked at how well dialysis removed a specific waste product called urea. However, dialysis treatments have improved a lot, and techniques like HDF can remove larger waste products, sometimes called 'middle molecules', which might make people feel better and improve their health.

This study wants to go beyond just measuring urea. It's comparing two main ways HDF is done: one where a larger amount of fluid is filtered (called 'high volume') and another where a smaller amount is filtered (called 'low volume'). The researchers want to see if removing more of these 'middle molecules' makes a real difference to how patients feel, their nutrition, and their overall health. They also want to understand how different levels of salt in the dialysis fluid affect how much extra fluid stays in a patient's body.

Ultimately, the aim is to find better ways to measure how 'good' a dialysis treatment is. This includes not just how well it cleans the blood, but also how it affects a patient's daily life, their comfort, their fluid levels, and their general health. The study hopes to develop a more complete picture of what 'adequate' dialysis means for patients.

Key takeaways

Compares different ways of doing kidney dialysis (Haemodiafiltration vs. Haemodialysis).
Focuses on removing larger waste products called 'middle molecules'.
Looks at how treatment affects how patients feel and their overall health.
Investigates how salt levels in dialysis fluid affect fluid balance.
Aims to find better ways to measure how effective dialysis truly is for patients.
It's an observational study, so no new treatments are given.

Who may be eligible?

In general, this study is looking for adults aged 18 or older who have kidney failure and have been having haemodialysis treatment for at least three months. You would also need to be able to understand the study information and agree to take part.

The research team would also need to feel that you are likely to be healthy enough to take part for at least six more months.

If you meet these general points, the study team would talk you through all the details to make sure it's right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have kidney failure and receive haemodialysis?
Have you been having haemodialysis for at least 3 months?
Are you able to understand study information and agree to take part?
Does your doctor think you're likely to be well enough for at least 6 more months?

Answer every question to see your result.

What does participation involve?

This is an 'observational study', which means you won't be given any new medicines or treatments. Instead, the researchers will be carefully looking at the information from your regular dialysis treatments. This would involve collecting data on how effective your dialysis is at clearing waste products, how you feel about your treatment, your eating habits, and how your body manages fluid. This information would come from your usual medical records and perhaps some questionnaires you might fill in about your well-being. The study doesn't mention extra visits, medication, or follow-up beyond your usual care, as they are observing your standard treatment.

Potential risks and benefits

Participating in this study involves no new treatments or procedures, so there aren't any direct medical risks beyond those of your standard dialysis care. The potential benefit is that your information will help doctors understand and potentially improve dialysis treatments for many patients in the future, leading to better quality of life. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

Lister Hospital, East and North Hertfordshire NHS Trust
Verified postcode
Stevenage, United Kingdom· Recruiting

Common questions

What is haemodiafiltration (HDF)?

HDF is a type of kidney dialysis that is often better at removing larger waste products from your blood compared to standard dialysis.

What are 'middle molecules'?

'Middle molecules' are certain waste products in your blood that are bigger than urea, which is what standard dialysis mainly focuses on removing.

Will I have to change my dialysis treatment?

No, this is an observational study. You will continue with your regular dialysis treatment as prescribed by your doctor. The study just collects information about it.

What does 'patient-reported outcomes' mean?

This means collecting information directly from you about how you feel, your quality of life, and any symptoms you experience, to understand the real-world impact of your treatment.

How long will the study last for me?

The study does not specify a duration for individual participation, but it's observing your ongoing standard treatment. You can discuss this with the research team.

How to find out more

Usama Afzal Butt, MBBS, MRCP (UK)

usama.butt1@nhs.net +441438284340 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.