RecruitingOBSERVATIONAL

Association of Middle Molecules Clearance With HDF Volume

This study is about a type of dialysis called Haemodiafiltration (HDF) which is used for people with severe kidney failure. Large studies have shown that HDF, especially when a higher volume of fluid is used, might help people live longer, but we don't fully understand why. We think this benefit could be linked to HDF being better at removing certain waste products from the blood, called 'middle molecules'. This study will observe patients already on HDF to see if there's a link between the amount of fluid used during their treatment and how well these 'middle molecules' are cleared from their blood. Understanding this could help doctors make dialysis treatments even better and more personal for patients.

At a glance

Status

Recruiting

Sponsor

East and North Hertfordshire NHS Trust

Enrolment target

400

Start

19 Jan 2024

Estimated completion

01 Jul 2025

End Stage Renal Disease

What is this study about?

If your kidneys aren't working properly, you might need a treatment called dialysis. There are different types, and one is called Haemodiafiltration, or HDF. Studies have suggested that HDF, especially when a good amount of fluid is used, might help people with kidney failure live longer. However, we're not entirely sure why this happens.

Doctors believe this benefit might be because HDF is better at removing specific waste substances from the blood, known as 'middle molecules.' These are a bit larger than other waste products. This study aims to investigate this idea. We want to see if there's a clear connection between the amount of fluid used during an HDF session and how well these 'middle molecules' are removed from a patient's blood.

Learning more about this connection is really important. It could help doctors decide the best way to set up HDF treatments for patients. Instead of just focusing on the fluid volume, they might be able to create prescriptions based on how well these 'middle molecules' are cleared, which could lead to better results for more people.

Key takeaways

The study aims to understand how a type of dialysis called HDF works better for some patients.
It focuses on whether more fluid used during HDF removes more specific waste products called 'middle molecules'.
Results could help doctors improve how they 'prescribe' HDF for patients.
Participation involves simply observing one of your regular HDF sessions and taking extra blood samples.
No new treatments or medications are given during the study.
You must be an adult, have kidney failure, and already be on HDF to join.

Who may be eligible?

This study is looking for adults aged 18 or over. To take part, you must already have severe kidney failure and be receiving dialysis treatment.

You also need to have been on Haemodiafiltration (HDF) specifically for at least one month. Doctors involved in the study will also need to believe that you are likely to be well enough to participate for at least six more months.

Unfortunately, if you are under 18, cannot easily understand and agree to take part, or if doctors think your health might make it difficult to participate for the next six months, you won't be able to join this particular study.

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 severe kidney failure and need dialysis?
Have you been receiving Haemodiafiltration (HDF) for at least the last month?
Do you feel able to clearly understand and agree to take part in the study?
Has your doctor indicated you are likely to be well enough for at least six more months?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you won't need to do anything extra outside of your usual HDF treatments. The study will involve observing one of your regular dialysis sessions. During this session, the researchers will simply record information that is usually taken during your treatment, such as how much fluid is used during your HDF.

They will also take some extra blood samples at the beginning and end of this specific dialysis session. These samples will be used to measure how well 'middle molecules' are being cleared from your blood. You won't be given any new medications or treatments as part of this study, and there's no long-term follow-up beyond this single observation session.

Potential risks and benefits

Taking part in this study may not directly benefit you, but the information we gather could help improve HDF treatment for future patients. There are minimal risks involved, as we will only be observing one of your routine dialysis sessions and taking a few extra blood samples, which is a common procedure. 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)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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

Common questions

What are 'middle molecules'?

'Middle molecules' are certain waste products that build up in your blood when your kidneys aren't working well. They are a bit larger than other waste products like urea.

What is HDF?

HDF (Haemodiafiltration) is a type of dialysis that helps clean your blood using two methods to remove waste: one called diffusion and another called convection.

Does this study involve new treatments?

No, you won't receive any new medications or treatments. We're just observing your routine HDF session and taking some additional blood tests.

How long will I be in the study?

Your involvement in the study will effectively be for a single, observed dialysis session. There is no long-term follow-up required after this.

Why is this research important?

Understanding how HDF removes waste products could help doctors create better and more personalised dialysis plans, potentially improving health for many patients.

How to find out more

Usama A Butt, MBBS,MRCP

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

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