AuthorisedTherapeutic confirmatory (Phase III)Interventional

Prevention of cardiac surgery-associated acute kidney injury through the use of sodium-glucose cotransporter 2 inhibitors

This research study is investigating if a medicine called Jardiance (known scientifically as a sodium-glucose cotransporter 2 inhibitor) can protect your kidneys after heart surgery. Sometimes, after major operations like heart surgery, people can experience kidney problems, known as acute kidney injury. The study aims to find out if taking Jardiance can reduce the chances of your kidneys getting worse, or needing special treatments like dialysis, or sadly, even death, in the 90 days after your surgery. This is a Phase III trial, meaning it's a large study to confirm if the treatment works and is safe for general use. It's for adults aged 18 and over, both men and women.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Hospital Clinico Universitario De Valladolid

Enrolment target

608

Start

16 Jan 2025

Cardiac-surgery associated acute kidney injury

What is this study about?

Heart surgery is a major operation that can sometimes cause problems with your kidneys. This is known as 'acute kidney injury' and means your kidneys suddenly stop working as well as they should. This study is looking into whether a drug called Jardiance could help prevent this from happening.

Jardiance is a type of medicine that's already used for other health conditions, and doctors are interested to see if it can also protect organs like the kidneys after stressful events like surgery. The main goal of this particular study is to see if Jardiance can stop your kidney function from getting significantly worse, prevent you from needing dialysis (a special treatment to clean your blood when your kidneys aren't working), or reduce the risk of death in the three months following your heart surgery.

This is a 'Phase III' study, which means it’s a big, important step in testing a new treatment. If the results are positive, it could mean that Jardiance might become a standard treatment to help protect people's kidneys after heart surgery in the future. The study involves giving some patients Jardiance and comparing their outcomes to others who don't receive it, to see if there's a clear benefit.

Key takeaways

This study is testing if Jardiance can prevent kidney problems after heart surgery.
It's for adults (18+) having heart surgery.
The study monitors kidney health for 3 months post-surgery.
It's a Phase III study, meaning it's a large-scale test.
Participation involves taking a study drug and having follow-up checks.

Who may be eligible?

This study is designed for adults aged 18 and older. Both men and women are welcome to take part.

The research team will need to check your general health and medical history to make sure this study is safe and appropriate for you. They will confirm if you meet all the necessary requirements before you can join. You don't need to have specific kidney problems before surgery to be considered for 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?
Are you scheduled to have heart surgery?
Are you able to take study medication as directed?
Are you able to attend follow-up appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would likely be asked to take the study drug, Jardiance, or a placebo (a dummy pill that looks like the real drug), for a set period before and after your heart surgery. You would have regular check-ups, blood tests, and other assessments to monitor your kidney function and general health.

This will involve visits to the hospital or clinic at specific times before and after your operation. The doctors will keep a close eye on how your kidneys are doing, especially during the first 90 days (about three months) after your surgery. The team will carefully explain the full schedule of appointments and what each one involves.

Potential risks and benefits

Taking part in a study means you might receive a new treatment that could help prevent kidney problems after heart surgery. However, there's also a chance the treatment might not help, or you might experience side effects, just like with any medicine. We understand that deciding to join a study is a big decision, and you can change your mind and leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
Spain

Common questions

What is 'acute kidney injury'?

It means your kidneys suddenly stop working as well as they should, which can sometimes happen after major surgery like heart surgery.

What is Jardiance?

Jardiance is a medicine that is usually given for other conditions, and this study is testing if it can also help protect kidneys after heart surgery.

Will taking part affect my heart surgery?

No, your heart surgery will go ahead as planned. This study focuses on your kidney health around the time of your surgery.

How long does the study follow-up last?

The main focus for your kidney health in this study is for the first 90 days, or about three months, after your heart surgery.

Do I have to take part?

No, it is your choice. You can decide not to take part, or to leave the study at any time, without it affecting your medical care.