Active not recruitingPHASE2INTERVENTIONAL

Interdialytic Peritoneal UltraFiltration in HemoDialysis Patients

This study is investigating a new approach to help patients with kidney failure who are on dialysis. When kidneys don't work well, salt can build up in the body's tissues, which isn't good for health. Standard dialysis three times a week might not remove all this extra salt effectively. This research is testing whether adding a gentle fluid treatment, called peritoneal ultrafiltration, twice a week between regular dialysis sessions can help remove this stored salt. For three weeks, 10 patients will have a special fluid put into their tummy through a small tube. This fluid helps draw out salt, and then it's drained away. Researchers will check salt levels before and after, and monitor patients for safety, to see if this method is effective and safe.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

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

Enrolment target

Start

01 Jan 2021

Estimated completion

30 Dec 2026

End Stage Renal Disease on Dialysis Hemodialysis Peritoneal Dialysis Nonosmotic Sodium Storage

What is this study about?

When your kidneys don’t work properly, they can't get rid of waste products and extra fluid and salt from your body. This can lead to a build-up of salt in your body’s tissues. While regular haemodialysis does a good job of cleaning your blood, it might not always be enough to remove all the extra salt that has built up in your tissues. This prolonged build-up of salt is not good for your long-term health.

This study, called "Interdialytic Peritoneal UltraFiltration in HemoDialysis Patients" (or iPUF for short), is trying a new approach to help with this. Researchers want to see if gently rinsing the inside of your tummy (peritoneal cavity) with a special fluid can help remove this extra salt between your regular haemodialysis sessions. This extra treatment is hoped to reduce the salt stored in your tissues more effectively than haemodialysis alone.

The main goal is to find out if this extra treatment is safe and effective in removing excess salt and fluid. If successful, this could potentially lead to better health and well-being for people living with kidney disease who are on dialysis.

Key takeaways

This study explores a new way to remove extra salt for dialysis patients.
It involves a gentle fluid treatment in the tummy twice a week, in addition to regular dialysis.
The aim is to improve overall health by reducing stored salt.
You'll need a small tube placed in your tummy for the treatment.
Safety and effectiveness will be carefully monitored throughout the study.

Who may be eligible?

This study is looking for volunteers who are adults (18 years or older) and are currently receiving haemodialysis up to three times a week. You might be a good fit if you often gain a significant amount of weight between your dialysis sessions, or if your current treatment sometimes struggles to remove enough fluid.

However, there are certain reasons why you might not be able to join. For example, if you have conditions that make peritoneal dialysis unsafe for you, or if you also have uncontrolled diabetes or an active infection. Similarly, if you can't have an MRI scan or if your salt levels are already very low, you wouldn't be able to participate. It's also important that you are able to attend all your regular haemodialysis sessions.

If you're interested, the study team will go through all the criteria with you to see if it's the right fit. You'll need to be willing to give your informed consent, meaning you understand the study and agree to take part.

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 currently have haemodialysis up to three times a week?
Do you often gain a lot of weight between your dialysis sessions?
Do you not have any other serious medical conditions that would prevent this treatment (like uncontrolled diabetes or a current infection)?
Are you able to have an MRI scan?
Are you willing and able to attend all study visits, including extra treatment sessions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would first have a small operation to place a thin, flexible tube called a Tenckhoff catheter into your tummy. This tube will be used to deliver the special fluid. After this, there will be a short 'run-in' period where the study team will check your kidney function and how your body handles fluid during your regular dialysis.

For three weeks, you would receive the extra treatment twice a week. This would happen right after your first two haemodialysis sessions of the week (usually Monday and Wednesday). A special sugar solution will be put into your tummy through the catheter, left there for two hours, and then drained away. You will be monitored during this process and for a few hours afterwards.

The extra treatment stops at the beginning of the fifth week (this is called the 'wash-out' period). During this fifth week and into the sixth, the study team will continue to watch you to see if there are any lasting effects from the treatment. You will also have MRI scans of your leg at the beginning and end of the study to measure changes in tissue salt. Your symptoms and blood pressure will be regularly checked throughout the entire study to ensure your safety. The total duration of active intervention and follow-up monitoring will be approximately six weeks.

Potential risks and benefits

Taking part in this study could potentially offer the benefit of better removal of excess salt and fluid from your body, which might improve your overall health if current methods aren't fully effective. However, as with any medical procedure, there are potential risks. The placement of the catheter for the tummy fluid could lead to mild discomfort or, rarely, infection. You will also need to spend extra time at the clinic for the additional treatments and monitoring. The research team will carefully monitor your health throughout the study to ensure your safety. It's very important to remember that participating is entirely voluntary, and you are free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

London Health Sciences Centre
Verified postcode
London, Canada

Common questions

What is peritoneal ultrafiltration?

It's a way to remove extra fluid and salt by gently rinsing the inside of your tummy using a special fluid passed through a small tube.

Why is salt build-up a problem?

When your kidneys don't work well, too much salt can stay in your body's tissues, which is not good for your long-term health.

How long will the extra treatment take?

The fluid will stay in your tummy for about two hours during each of the twice-weekly extra sessions.

Will I still have my regular dialysis?

Yes, you will continue with your usual three-times-a-week haemodialysis sessions as scheduled.

What is the small tube for?

A small tube (catheter) will be placed in your tummy to allow the special fluid to go in and out for the extra treatment.