Personalisation of Mean Arterial Pressure in Adult Patients With Cardiogenic Shock
This research is for adults with a very serious heart condition called cardiogenic shock, where the heart can't pump enough blood. Doctors usually aim for a standard blood pressure (called 'mean arterial pressure' or MAP) in these patients. However, we think that simply reaching this standard pressure might not be enough for everyone, especially if there's a lot of fluid build-up around the heart. This study is comparing two ways to manage blood pressure: the usual standard target, and a new 'personalised' target. The personalised approach considers the fluid pressure around the heart to set a more individualised blood pressure goal. We want to see if this personalised approach helps organs work better and improves a patient's chance of recovery compared to the standard method.
At a glance
What is this study about?
Cardiogenic shock is a very serious heart problem where your heart isn't strong enough to pump enough blood to your body. This can mean your organs don't get the oxygen and nutrients they need, which is very dangerous. Despite advances in care, unfortunately, many people with this condition still don't survive.
Doctors usually try to keep a certain blood pressure, called mean arterial pressure (MAP), to help get blood to your organs. We know that if blood pressure is too low, it can lead to worse outcomes. However, sometimes there's a lot of pressure from fluid build-up (called 'venous congestion') that can make it harder for blood to reach your organs, even if your MAP looks okay on paper. This hidden pressure might mean your organs aren't really getting enough blood.
This study aims to find out if setting a more individualised blood pressure target, considering this fluid pressure, can improve how well your organs work and ultimately help you recover better. We're comparing this 'personalised' approach to the usual standard blood pressure management. The idea is that by carefully adjusting the blood pressure goal based on your body's specific needs, we might give your organs a better chance.
Key takeaways
- This study explores a new way to manage blood pressure for a serious heart condition.
- It compares standard blood pressure targets with personalised targets.
- The goal is to improve organ function and survival for patients with cardiogenic shock.
- Eligibility is for adults diagnosed with severe cardiogenic shock.
- Participation involves close monitoring as part of your ongoing hospital care.
Who may be eligible?
To join this study, you would need to be an adult (18 years or older) and have been diagnosed with cardiogenic shock, which is a serious heart problem. You would also need to fit specific criteria related to how severe your condition is, as determined by your doctors.
There are also some reasons why you wouldn't be able to join. For example, if you've been on certain heart medications for more than a day, or if you already have very high blood pressure when first assessed for the study. People with severe long-term kidney disease, those on dialysis, or those who recently had a heart attack and recovery within the last week would also not be able to participate.
Additionally, if you are pregnant, breastfeeding, or already on certain specialist heart support machines, you wouldn't be eligible. Your doctors will carefully check all these points to see if this study is suitable for you.
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?
- Have you been diagnosed with cardiogenic shock?
- Do you have severe kidney disease or are on dialysis?
- Have you just recovered from a heart attack within the last week?
- Are you pregnant or breastfeeding?
- Are you already on special life support machines for your heart?
What does participation involve?
If you join this study, you would be assigned to one of two groups by chance, like flipping a coin: one group would receive personalized blood pressure management, and the other would receive standard management. Your medical team would closely monitor your blood pressure and other vital signs. They would adjust medications as needed based on which group you are in. You would undergo regular medical assessments, which might include blood tests and other routine measurements, to check how your organs are working. There are no additional study visits beyond your normal hospital care for cardiogenic shock. The total time you would be involved in the study would depend on your recovery from cardiogenic shock, with follow-up on your health outcomes.
Potential risks and benefits
Locations (11)
- CHU d'Amiens-PicardieVerified postcodeAmiens, France· Not yet recruiting
- Hôpital Henri MondorVerified postcodeCréteil, France· Not yet recruiting
- Hôpital Privé Jacques CartierVerified postcodeMassy, France· Not yet recruiting
- CMC Ambroise Paré - HartmannVerified postcodeNeuilly-sur-Seine, France· Recruiting
- CHU d'OrléansVerified postcodeOrléans, France· Not yet recruiting
- Hôpital LariboisièreVerified postcodeParis, France· Not yet recruiting
- Hôpital CochinVerified postcodeParis, France· Not yet recruiting
- Clinique NCT + /Saint-GatienVerified postcodeSaint-Cyr-sur-Loire, France· Not yet recruiting
- Centre Cardiologique du NordVerified postcodeSaint-Denis, France· Not yet recruiting
- CHRU de StrasbourgVerified postcodeStrasbourg, France· Not yet recruiting
- CHU de ToulouseVerified postcodeToulouse, France· Not yet recruiting
Common questions
What is cardiogenic shock?
It's a very serious condition where your heart can't pump enough blood to meet your body's needs, leading to organs not getting enough oxygen.
What is 'personalised MAP'?
It's a new way to set your blood pressure target, taking into account the pressure from fluid around your heart to make the target more individual to you.
Who is funding this research?
The information provided does not specify the funding source for this clinical trial.
Will I know which treatment group I'm in?
Participants are assigned to groups randomly (like a lottery) and usually won't know which specific treatment approach they are receiving to keep the results unbiased.
What happens if I don't want to continue in the study?
You have the right to withdraw from the study at any time without giving a reason, and your medical care will not be affected.
How to find out more
Armand MEKONTSO DESSAP, MD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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