RecruitingNAINTERVENTIONAL

Norepinephrine Weaning Guided by the Hypotension Prediction Index in Vasoplegic Shock After Cardiac Surgery

After heart surgery, some patients might get very low blood pressure, called vasoplegic shock. A common treatment for this is a medicine called norepinephrine. While helpful, taking it for too long or in too high a dose can cause problems. This study is testing a new way to help doctors decide when and how to safely reduce norepinephrine. They are using a special device that can predict when a patient is likely to have a drop in blood pressure. The goal is to see if using this device helps patients stop norepinephrine sooner, which could lead to a better recovery and fewer side effects. The study involves patients recovering from heart surgery.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Hospitalier Universitaire, Amiens

Enrolment target

142

Start

01 Sep 2023

Estimated completion

01 Jul 2025

Vasoplegia Shock Norepinephrine Surgery

What is this study about?

When you have heart surgery, especially with a heart-lung machine, your body can sometimes react by having very low blood pressure. This is called vasoplegic shock. It means your blood vessels become too relaxed, and your heart might not be able to pump blood around your body effectively enough. This can be serious and make your recovery harder.

A medicine called norepinephrine is often used to help raise blood pressure and is very important for treating this condition. However, doctors sometimes worry about giving too much of this medicine or giving it for too long, as it can have its own side effects. Finding the right balance is key to helping you recover well.

This study is looking at a new way to guide doctors in reducing norepinephrine. They are using a special device that can predict if your blood pressure is about to drop. Think of it like a smart alarm that can warn doctors before a problem happens. The idea is that if doctors know when your blood pressure might drop, they can more carefully lower your norepinephrine without risking sudden problems. The main goal is to see if this new approach helps patients stop taking norepinephrine sooner, which could make their recovery smoother and potentially lead to better overall health.

Key takeaways

The study aims to improve how a common blood pressure medicine (norepinephrine) is reduced after heart surgery.
It uses a new device to predict low blood pressure episodes, hoping to help patients stop the medicine sooner.
Participation involves special monitoring for up to 3 days and follow-up checks at discharge and 30 days.
The goal is to potentially reduce medicine duration, which might lead to better recovery.
This study is only for adult patients having specific types of heart surgery at Amiens-Picardy University Hospital.

Who may be eligible?

This study is looking for adults aged 18 or older who are having heart surgery at Amiens-Picardy University Hospital. Specifically, you would need to be having certain types of heart surgery, such as a bypass or valve replacement, where a heart-lung machine is used.

After your surgery, you would need to develop low blood pressure (vasoplegic syndrome) that requires treatment with norepinephrine. You’d also need to be somewhat stable, with your blood pressure above a certain level for at least four hours while on norepinephrine.

There are also some reasons why you wouldn't be able to join. For example, if you have certain types of irregular heartbeats, are pregnant, or are already taking other specific heart medicines. People who are very unwell, such as needing life support and having very low body temperature, or those with severe kidney problems needing dialysis might also not be able 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?
Are you having specific heart surgery (like bypass or valve replacement) using a heart-lung machine?
Will you be treated at Amiens-Picardy University Hospital?
Will you likely need norepinephrine for low blood pressure after surgery?
Are you able to agree to take part in the study?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, your doctors will be using a special device to help guide decisions about your norepinephrine medication for up to 72 hours (3 days) after your heart surgery. This device will help them predict changes in your blood pressure. You will continue to receive the usual medical care, but the way your norepinephrine is adjusted might be different.

To see how well this new approach works, the study team will keep track of your health for a longer period. They will check in with you several times: at the end of the 72-hour period, when you leave the hospital, and one month (30 days) after you joined the study. During these check-ups, they will collect information about your health, listen to how you are feeling, and look at some of your medical test results. No extra visits to the hospital are required beyond your normal appointments.

Potential risks and benefits

Participating in this study might offer a potential benefit if the new method helps you stop norepinephrine sooner, which could lead to a quicker and smoother recovery with fewer side effects from the medicine. However, there are no guarantees your personal outcome will be different. As with any medical study, there's a small chance of unforeseen risks, though the new approach aims to improve care. 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)

CHU Amiens Picardie
Verified postcode
Amiens, France· Recruiting

Common questions

What is vasoplegic shock?

It's when your blood vessels become too relaxed, causing very low blood pressure, often after heart surgery. It needs treatment to help your heart pump blood effectively.

What is norepinephrine?

It's a medicine used to raise low blood pressure, helping your heart and blood vessels work better. It's common after serious surgery.

What is the special device used in the study?

It's a device that can predict when your blood pressure might drop, helping doctors make informed decisions about your medication.

How long will I be involved in the study?

The special protocol for adjusting your medicine lasts up to 72 hours after surgery. The study team will then check in with you at hospital discharge and 30 days after you started.

Will taking part change my normal care?

Your usual medical care will continue, but the way your norepinephrine is managed might be guided by the new device. You will still receive the best care for your condition.

How to find out more

Christophe Beyls, MD

beyls.christophe@chu-amiens.fr 0322087866 Official trial record

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