Not yet recruitingNAINTERVENTIONAL

Assessment of a Wearable Ultrafiltration Device

Currently, people with kidney failure need dialysis in hospital to clean their blood, but removing fluid quickly during these sessions can harm their heart and other organs. This study is testing a new, small device that can be worn at home between hospital dialysis sessions. It doesn't clean the blood but gently removes extra fluid, which current treatments often can't do effectively. If successful, this device could make a big difference. It might reduce the stress on the body caused by rapid fluid removal, potentially helping people feel better and live longer by protecting their organs from damage, especially if they struggle to tolerate fluid removal during their standard dialysis sessions.

At a glance

Status

Not yet recruiting

Phase

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Enrolment target

Start

01 Jul 2026

Estimated completion

31 Dec 2027

Hemodialysis Ultrafiltration

What is this study about?

When your kidneys don't work properly, harmful waste products and too much fluid can build up in your body. To help with this, many patients need a treatment called dialysis, usually done in a hospital several times a week. During dialysis, a machine cleans your blood and removes extra fluid. However, removing a lot of fluid quickly during these short sessions can put a lot of stress on your body, similar to tiny heart attacks or strokes, and can damage vital organs over time.

Because of these harmful effects, scientists are trying to find better ways to manage fluid in people on dialysis. Until now, there hasn't been a good way to remove extra fluid gently and slowly between hospital dialysis sessions. Our researchers have developed a completely new, small, and simplified device that you can wear. This device won't replace your regular dialysis for cleaning your blood, but it can safely and gently take off extra fluid when you're not in the hospital.

If this study works well, it would be the first time a wearable device has successfully helped dialysis patients remove fluid at home. This could be a huge step forward for two main reasons: firstly, it could help patients who find it difficult to have all the necessary fluid removed during their short dialysis sessions in hospital, which should make them feel better and potentially live longer. Secondly, even if you feel okay after dialysis, rapid fluid removal can still cause silent damage to your organs, and this new device could help reduce that harm.

Key takeaways

A new wearable device is being tested for fluid removal in dialysis patients.
It aims to remove fluid gently between standard hospital dialysis sessions.
The goal is to reduce stress on organs and improve patient well-being.
This device would not replace regular dialysis for blood cleaning.
It could offer a new way to help manage fluid overload for those who struggle with rapid removal.

Who may be eligible?

To be considered for this study, you must be 18 years old or older and currently receive hemodialysis three times a week. You also need to have a central venous line for your dialysis treatment. Importantly, you must be willing and able to understand the study and agree to take part.

One key thing the researchers are looking for is if you have trouble removing enough fluid during your regular dialysis. This could mean that, on average, you gain a lot of fluid between sessions (at least 4% of your dry weight) in the last month, or that your doctors find it hard to get you to your 'dry weight' (the weight your body is when all extra fluid has been removed) with your current dialysis schedule. It could also mean you need extra dialysis sessions just to remove enough fluid.

There are also some reasons why you might not be able to join. For example, if you have an active infection, or if you don't regularly attend your scheduled dialysis appointments, you wouldn't be able to participate in this 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 kidney failure and receive hospital dialysis three times a week?
Do you have a central venous access (like a catheter) for your dialysis?
Do you or your doctors find it hard to remove enough fluid during your regular dialysis sessions?
Are you able to agree to take part in the study and follow instructions?

Answer every question to see your result.

What does participation involve?

The detailed steps of taking part in this study are not fully described here, but generally, clinical trials involve regular visits to the study clinic or hospital where doctors and nurses will monitor your health closely. This usually includes physical examinations, blood tests, and checking how the new device is working. You would likely be asked to wear the new fluid-removal device at home for certain periods between your regular hospital dialysis sessions. Researchers would then collect information on how much fluid the device removes and how you feel. There would also be a follow-up period to see the longer-term effects. The total length of your participation would be explained by the study team.

Potential risks and benefits

If you take part in this study, a potential benefit could be a gentler way to remove excess fluid from your body, which might reduce the strain on your heart and other organs during regular dialysis, making you feel better and possibly improving your long-term health. However, as with any new medical device or treatment, there could be unknown risks or side effects that the doctors will explain fully. You will be able to leave the study at any time and for any reason, without it affecting your medical care.

Locations (1)

London Health Sciences Centre
Verified postcode
London, Canada

Common questions

What is hemodialysis and why is it important?

Hemodialysis is a treatment for kidney failure that uses a machine to clean your blood and remove extra fluid, helping your body work properly when your kidneys no longer can.

What is the new device for?

The new device helps gently remove extra fluid from your body between your regular hospital dialysis sessions. It doesn't clean your blood like dialysis does.

Will this device replace my regular dialysis?

No, this device is designed to work alongside your regular dialysis treatments, not replace them. It's meant to help manage fluid more gently.

Is this device worn outside of the hospital?

Yes, if successful, this would be a wearable device that you could use at home between your hospital dialysis sessions.

Who is funding this study?

The information provided does not specify the funding source for this clinical trial.

How to find out more

Jarrin Penny, RN, PhD, CNeph (C)

jarrin.penny@lhsc.on.ca 519-685-8500 Official trial record

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