RecruitingOBSERVATIONAL

Mic Mac: Micro- and Macrocirculatory Assessment During Cardiac Surgery in Patients at Risk of Vasoplegic Syndrome: A Prospective Study.

This research is investigating why some people experience a condition called 'vasoplegic syndrome' after heart surgery. This condition causes a significant and persistent drop in blood pressure, requiring special medications to keep it stable. During heart surgery, a special pump called extracorporeal circulation (often called a 'heart-lung machine') takes over for your heart while surgeons work. After this, your blood pressure can sometimes drop too much. Researchers want to understand why this happens and how to better manage it. They will use standard monitoring tools along with new sensors placed on your earlobe and palm to check blood circulation quality during and for 48 hours after your surgery. The goal is to learn if these observations can help them better understand and treat this complication.

At a glance

Status

Recruiting

Sponsor

European Georges Pompidou Hospital

Enrolment target

Start

10 Feb 2025

Estimated completion

31 Dec 2026

Vasoplegic Syndrome of Cardiac Surgery

What is this study about?

Imagine you're having heart surgery. Sometimes, after the surgery, especially when a heart-lung machine has been used, your blood pressure can drop very suddenly and stay low. This is called vasoplegic syndrome, and it means your body needs extra help from medicines to keep your blood pressure stable. Doctors know this can happen, but they don't fully understand why, and it can be a serious complication.

This study aims to make sense of vasoplegic syndrome. Researchers are carefully watching how blood moves in your body, both the larger blood vessels and the tiny ones, during your heart surgery and for two days afterwards in the intensive care unit (ICU). They'll be using the usual monitors, plus some new, gentle sensors placed on your earlobe and the palm of your hand. These sensors help them see how well blood is flowing in a detailed way.

The main goal is to figure out what goes wrong in the body that causes this blood pressure drop. By understanding the causes better, doctors hope to find new and more effective ways to prevent or treat vasoplegic syndrome in the future. This research is a step towards making heart surgery even safer and improving recovery for patients.

Key takeaways

This study investigates why blood pressure drops in some patients after heart surgery.
It uses special skin sensors to monitor blood flow during and after surgery.
The goal is to better understand vasoplegic syndrome and find improved treatments.
Participation involves extra monitoring and a few extra blood/urine samples.
The study aims to improve safety and recovery for future heart surgery patients.

Who may be eligible?

To join this study, you would need to be an adult (18 years or older) scheduled for heart surgery that uses a heart-lung machine. The doctors would need to confirm that you have at least three specific risk factors that make it more likely for someone to develop the blood pressure problem this study is investigating. These risk factors include things like having weaker heart function, needing complex heart surgery, or having certain existing health conditions like type 2 diabetes or kidney disease.

However, there are also reasons you might not be able to join. For example, if you're pregnant, if your heart is already very unstable before surgery, or if you have certain other serious health issues like an ongoing infection or kidney failure where you don't produce urine, you wouldn't be able to take part. Also, if you already have certain advanced heart devices or specific hormone-related problems, you would not 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 old or older?
Are you having heart surgery where a heart-lung machine will be used?
Do you have certain health conditions that put you at higher risk for low blood pressure after surgery?
Are you not pregnant?
Are you generally stable and not currently suffering from a severe infection or certain other serious health issues?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the research team will keep a close eye on you during your heart surgery and for about two days (50 hours) afterwards in the intensive care unit. They will use the usual monitors that everyone has during this type of surgery to check your vital signs. In addition, they will place small, non-invasive sensors on your earlobe and the palm of your hand. These sensors will help them learn more about how blood is flowing in your body. They will also take some extra blood and urine samples at different points: before surgery, during key moments of the surgery, and then at 12, 24, and 50 hours after surgery ends. The total duration of active study involvement for monitoring and samples is around two days after your surgery, though the researchers may continue to follow your general recovery as part of your standard care.

Potential risks and benefits

Taking part in this study may offer the benefit of contributing to new knowledge that could help future patients who need heart surgery. While there's no direct personal benefit guaranteed, understanding this condition better could lead to improved care. The main risks involve the few extra blood and urine samples, which are generally very safe but carry common small risks like minor bruising or discomfort. The skin sensors are non-invasive and should not cause any harm. Remember, you can choose to withdraw from the study at any time without affecting your standard medical care.

Locations (1)

Georges Pompidou European Hospital
Verified postcode
Paris, France· Recruiting

Common questions

What is vasoplegic syndrome?

It's when your blood pressure drops unexpectedly low and stays low after heart surgery, needing extra medicine to keep it stable.

Why is this research important?

It aims to understand why vasoplegic syndrome happens so doctors can find better ways to prevent or treat it, making heart surgery safer.

What does 'extracorporeal circulation' mean?

It's a medical term for the heart-lung machine that takes over for your heart during surgery when it needs to be stopped.

Are the extra sensors painful?

No, the sensors are placed gently on your skin (earlobe and hand) and are designed to be non-invasive and comfortable.

Will I get special treatment in the study?

You will receive excellent standard medical care, and the study involves extra monitoring and samples to learn more, not different treatments.

How to find out more

Hélène NOUGUE, MCU-PH

helene.nougue@aphp.fr +331 56 09 25 94 Official trial record

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