RecruitingPHASE3INTERVENTIONAL

Reducing Cardiac-surgery Associated Acute Kidney Injury Occurence by Administering Angiotensin II

This research aims to find out if a medicine called Angiotensin II can help prevent kidney problems in adults who are having heart surgery, such as bypass or valve operations. After this type of surgery, some people can develop Acute Kidney Injury (AKI), which means their kidneys get damaged. This study is comparing Angiotensin II with a common medication, Noradrenalin, which is currently used to maintain blood pressure during surgery. Doctors want to see if Angiotensin II is better at protecting the kidneys. AKI can lead to serious health issues and longer hospital stays, so finding ways to reduce it is very important for patients' recovery and well-being.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Universität Münster

Enrolment target

1,022

Start

31 Mar 2025

Estimated completion

01 Apr 2027

Cardiac Surgery Vasoplegia

What is this study about?

When people have heart surgery, especially operations like bypass surgery or valve replacements, their kidneys can sometimes be affected. This is a common issue and can lead to what doctors call Acute Kidney Injury, or AKI. AKI means the kidneys aren't working as well as they should, which can cause problems with recovery and lead to longer stays in hospital. Finding ways to protect the kidneys during and after heart surgery is therefore very important for patient health.

During heart surgery, patients might experience a drop in blood pressure. To help with this, doctors often give medicines called 'vasopressors' to keep the blood pressure stable. Normally, they use a medicine called Noradrenalin. However, this study is investigating another medicine called Angiotensin II. They want to see if Angiotensin II might be more effective at protecting the kidneys specifically in patients undergoing heart surgery, compared to Noradrenalin.

The researchers want to fill a gap in what we know. While previous studies have hinted that Angiotensin II could be helpful for kidney protection in other surgical situations, there isn't clear evidence yet for heart surgery patients. This study will carefully compare the effects of Angiotensin II with Noradrenalin to understand if it can reduce the chances of developing moderate or severe kidney problems. The hope is that this could lead to better ways to care for patients having heart surgery.

Key takeaways

This study compares two medicines (Angiotensin II and Noradrenalin) during heart surgery.
It aims to see if Angiotensin II can better protect kidneys from damage after surgery.
Participation involves routine monitoring and tests around your surgery time.
The findings could lead to improved care for heart surgery patients.
You have the right to leave the study at any time.
This is a 'Phase 3' study, meaning the medicine has been tested before.

Who may be eligible?

This study is looking for adult patients, aged 18 or over, who are having heart surgery that uses a heart-lung machine (cardiopulmonary bypass). This includes operations like coronary artery bypass grafts (CABG) or valve surgery, or a combination of both. You would need to have been identified as having a higher chance of developing kidney problems after surgery, based on a special score from your doctor.

There are also some reasons why you wouldn't be able to join the study. For example, if you're having very complex aortic surgery, a transplant, or if you're already receiving medications to support your blood pressure before the surgery. You also can't take part if you're already on dialysis for kidney failure, or if you've had kidney injury recently or severe long-term kidney disease. Some other conditions like very high blood pressure, severe lung problems affecting the heart, or being pregnant or breastfeeding would also mean you can't join.

Finally, if you've been in another study looking at kidney function in the last three months, or if you're allergic to the study medication or its ingredients, you wouldn't be able to participate.

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 an adult aged 18 or older?
Are you having open-heart surgery (like bypass or valve repair) that uses a heart-lung machine?
Has your doctor told you that you have a higher estimated chance of kidney problems after surgery?
Are you NOT pregnant or breastfeeding?
Are you NOT currently on dialysis for kidney failure?
Are you NOT having very complex heart surgery (like a full aortic arch replacement)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive either Angiotensin II or Noradrenalin during your heart surgery, similar to how medicines are given routinely. Doctors will closely monitor your health before, during, and after your operation. This will involve regular blood and urine tests to check your kidney function. You will also have standard measurements like blood pressure and heart rate taken. The study team will follow your progress while you are in the hospital. The total duration of your participation in the study will mostly involve the time spent around your surgery and recovery in the hospital, with follow-up assessments until you are discharged.

Potential risks and benefits

Taking part in this study could potentially help us understand if a new approach can better protect kidneys during heart surgery. While there's no guarantee of direct benefit to you, your involvement could help improve future care for other patients. As with any medication, there can be side effects, but both Angiotensin II and Noradrenalin are used to manage blood pressure in hospital settings. The study team will closely monitor you for any potential issues. Remembering that you can choose to leave the study at any time, without it affecting your usual medical care, is important.

Locations (4)

Deutsches Herzzentrum der Charité
Verified postcode
Berlin, Germany· Recruiting
University Hospital Bonn
Verified postcode
Bonn, Germany· Recruiting
University Medical Center Mainz
Verified postcode
Mainz, Germany· Recruiting
University Hospital Münster
Verified postcode
Münster, Germany· Recruiting

Common questions

What is 'Acute Kidney Injury' (AKI)?

AKI means your kidneys suddenly stop working as well as they should. This can happen after surgery and usually improves, but in some cases, it can be serious.

Why is this study important?

This study aims to discover if a particular medicine can better protect your kidneys during heart surgery, which could improve your recovery and reduce complications.

Will I know which medicine I'm getting?

No, in this type of study, you won't know if you're receiving Angiotensin II or Noradrenalin. This helps ensure the results are fair and unbiased.

What if I change my mind about participating?

You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Will my information be kept private?

Yes, all your personal and medical information will be kept strictly confidential and anonymous in the study records.

How to find out more

Alexander Zarbock, MD

pan-aki@ukmuenster.de +49-251-8347252 Official trial record

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