Active not recruitingNAINTERVENTIONAL

Post-Marketing Study to Assess the Safety & Efficacy of RenalGuard® Therapy for Prevention CSA-AKI

This study aims to find out if a treatment called RenalGuard Therapy can prevent acute kidney injury (AKI) in people undergoing heart surgery. AKI is a sudden problem where kidneys stop working properly. Some patients are more likely to get AKI after heart surgery. The study will compare RenalGuard Therapy to the usual care patients receive now. Half the patients will get RenalGuard, which helps manage how much urine the kidneys make during and after surgery. The other half will receive standard care. Researchers will check for kidney injury within 72 hours of surgery and follow patients up for 90 days. The goal is to see if RenalGuard can help reduce the chance of kidney problems.

At a glance

Status

Active not recruiting

Phase

Sponsor

CardioRenal Systems, Inc.

Enrolment target

300

Start

23 Feb 2025

Estimated completion

30 Apr 2028

AKI - Acute Kidney Injury Cardiac Surgery Associated - Acute Kidney Injury

What is this study about?

When you have heart surgery, sometimes your kidneys can get a sudden injury called 'acute kidney injury' (AKI). This means your kidneys might struggle to clean your blood as they should. It's a serious problem, and doctors are always looking for better ways to prevent it, especially in patients who are more likely to develop it.

This study is looking at a special treatment called RenalGuard Therapy. This treatment helps manage the fluids in your body and how much urine your kidneys produce during and shortly after your heart operation. The idea is that by carefully controlling this, we might be able to protect your kidneys from injury. The study wants to see if using RenalGuard Therapy is better at preventing AKI than the usual care given to patients after heart surgery.

Researchers will be splitting patients into two groups. One group will receive the RenalGuard Therapy, while the other group will receive the standard care that hospitals currently provide. All patients will have the same general anaesthesia and heart surgery procedures. Doctors will then compare how many people in each group develop AKI to see if RenalGuard Therapy makes a difference.

Key takeaways

A study for patients having certain types of heart surgery.
Aims to prevent acute kidney injury (AKI) after surgery.
Compares a new treatment (RenalGuard Therapy) to standard care.
Requires participants to have some risk factors for AKI.
Follow-up checks happen for up to 90 days after surgery.
Participation is voluntary and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) and be able to understand and agree to take part. You must be having a planned heart operation that involves using a heart-lung machine, such as a bypass surgery or valve repair/replacement.

You also need to have at least one of several factors that might make you more likely to get kidney injury after surgery. These could include having some existing kidney problems, being 75 or older, having a more complex surgery, having a weaker heart, or having diabetes.

You would not be able to join if you need emergency surgery, if your surgery doesn't use a heart-lung machine, or if you already have severe kidney disease or are on dialysis. Also, if you're taking very high doses of certain water tablets or are already taking part in another drug or device study, you wouldn't be eligible.

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 or older?
Are you having planned heart surgery that uses a heart-lung machine (e.g., bypass or valve surgery)?
Do you have at least one thing that might make you more likely to get kidney problems after surgery (like certain kidney issues, being over 75, or having diabetes)?
Are you NOT having emergency surgery?
Are you NOT already on dialysis or taking very high doses of certain water tablets?
Are you NOT already in another medicine or device study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned by chance (like flipping a coin) to one of two groups. One group will receive the RenalGuard Therapy during your surgery and for about 6-7 hours afterwards in the Intensive Care Unit. The other group will receive the usual care for heart surgery patients.

Your general anaesthesia and heart surgery procedure will be the same regardless of which group you are in. Researchers will keep a close eye on you for up to 7 days after your surgery, or until you leave the hospital, whichever comes first. You'll also have a final check-up about 90 days (about 3 months) after your surgery to see how you're doing long-term. This will involve some assessments to see if your kidneys have been affected.

Potential risks and benefits

Taking part in a study like this may or may not directly benefit you, but it could help doctors learn how to better protect patients from kidney injury after heart surgery in the future. As with any medical procedure, there are potential risks, though researchers will closely monitor you for any problems. You will be told about all known risks before you agree to take part. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (8)

Jessa Medica Center
Verified postcode
Hasselt, Belgium
TUM Klinikum Deutsches Herzzentrum
Verified postcode
Munich, Germany
Uniklinikum Munster
Verified postcode
Münster, Germany
Rambam Medical Center
Verified postcode
Haifa, Israel
Rabin Medical Center - Belinson Campus
Verified postcode
Petah Tikva, Israel
Hospital de la Santa Creu i Sant Pau
Verified postcode
Barcelona, Spain
Hospital Universitario Ramón y Cajal
Verified postcode
Madrid, Spain
Sahlgrenska University Hospital
Verified postcode
Gothenburg, Sweden

Common questions

What is AKI?

AKI stands for Acute Kidney Injury, which means your kidneys suddenly stop working as well as they should.

What is RenalGuard Therapy?

It's a treatment that helps manage your body fluids and how much urine your kidneys make during and after heart surgery.

Will I know if I'm getting RenalGuard Therapy?

No, you will be randomly assigned to either the RenalGuard group or the standard care group, and you won't know which one you are in.

How long will I be in the study?

You'll be monitored for up to 7 days after surgery or until hospital discharge, with a final check-up 90 days after surgery.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time without it affecting your usual medical care.