HYdrocortisone and VAsopressin in Post-RESuscitation Syndrome
This research trial is investigating whether a combination of two medicines, hydrocortisone and arginine-vasopressin (AVP), can help people who have survived a heart attack and CPR. After CPR, many patients experience a serious condition called 'post-resuscitation syndrome,' which can affect multiple organs and the brain. This can lead to very low blood pressure and organ failure. The study aims to find out if giving hydrocortisone and AVP helps to stabilise blood pressure, improve survival, and aid brain recovery better than the usual treatments. Patients will be randomly assigned to receive either these medications or a dummy treatment (placebo) to see which approach is more effective.
At a glance
What is this study about?
When someone has a heart attack and needs CPR, their body goes through a lot of stress. Even after their heart starts beating again, they can develop a serious condition called 'post-resuscitation syndrome.' This condition can cause many organs, including the brain, to struggle. Often, a major problem is very low blood pressure, which can lead to organs not getting enough blood and oxygen.
Doctors believe that this low blood pressure might be partly due to a hormonal imbalance in the body after such a traumatic event. This study is testing if giving extra hormones – specifically hydrocortisone and a medicine called arginine-vasopressin (AVP) – could help. These medicines might support the body in keeping blood pressure stable and help organs recover, potentially improving a patient's chances of survival and brain function.
The main goal of this study is to see if giving patients these two medicines works better than the usual treatment. Researchers will compare how well patients survive and how well their brains recover 30 days after their heart attack. They hope to find a new way to help people get better after a heart attack and CPR.
Key takeaways
- The study tests two medicines (hydrocortisone, AVP) for people after heart attack and CPR.
- It aims to improve survival and brain recovery after post-resuscitation syndrome.
- Patients will be randomly assigned to receive medicines or a dummy treatment (placebo).
- Treatment involves drips and injections given in the intensive care unit.
- All participants will be closely monitored for safety and recovery.
Who may be eligible?
This study is looking for adults aged 18 or older who have had a heart attack, received CPR, and whose heart started beating normally again for at least 30 minutes. To join, patients must also be experiencing very low blood pressure (shock) within the first day after their heart attack, which isn't getting better with standard treatments and requires specific strong medicines to raise blood pressure.
However, some people cannot take part. This includes those whose heart attack was caused by a serious injury or brain problem, or if their shock is due to major bleeding. If you already have a condition where your body doesn't produce enough hydrocortisone, or if you're already taking steroid medicines, you won't be able to join. Patients who are pregnant or breastfeeding, have recently had stomach bleeding, or are receiving certain life support treatments also can't participate. You need to be able to give your consent, or have a close relative who can give consent 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?
- Did you have a heart attack and receive CPR, with your heart beating again for at least 30 minutes?
- Are you experiencing very low blood pressure (shock) that started within 24 hours of your heart attack, needing strong medicines to raise it?
- Do you (or your close relative) agree to participate and provide consent?
- Are you NOT pregnant or breastfeeding?
- Are you NOT currently taking steroid medicines or receiving certain advanced life support treatments?
What does participation involve?
If you or your loved one takes part in this study, you will be randomly placed into one of four groups – like drawing names out of a hat. This means you will either receive hydrocortisone, AVP, both medicines, or a dummy treatment (placebo) instead of the active drug. Doctors and patients won't know which treatment is being given.
The AVP medicine would be given as a drip into a vein and adjusted to keep blood pressure at a target level for up to 3 days. The hydrocortisone would be given as an injection into a vein, first a higher dose, then smaller doses every 6 hours for 7 days. At the end of the 7 days, this medicine would be stopped without gradually reducing the dose.
Your medical team will closely monitor your condition and recovery throughout your time in the Intensive Care Unit (ICU). The study will focus on your survival and brain recovery 30 days after your heart attack. There won't be extra visits just for the study; all monitoring will happen as part of your normal hospital care.
Potential risks and benefits
Locations (14)
- Intensive care unit, CHU Amiens- PicardieVerified postcodeAmiens, France· Recruiting
- Intensive care unit, CHU AngersVerified postcodeAngers, France· Recruiting
- Intensive care unit, CHI Robert BallangerVerified postcodeAulnay-sous-Bois, France· Recruiting
- Medical Intensive Care Unit, Ambroise Paré hospital, APHPVerified postcodeBoulogne-Billancourt, France· Withdrawn
- Intensive care unit, CH public du CotentinVerified postcodeCherbourg, France· Recruiting
- Intensive care unit, CHU DijonVerified postcodeDijon, France· Recruiting
- Intensive care unit, Hospices civils de LyonVerified postcodeLyon, France· Recruiting
- Intensive care unit, Hôpital Jacques CartierVerified postcodeMassy, France· Recruiting
- Intensive care unit, CHU MontpellierVerified postcodeMontpellier, France· Recruiting
- Intensive care unit, Brabois hospitalVerified postcodeNancy, France· Recruiting
- Intensive care unit, Hotel Dieu hospitalVerified postcodeNantes, France· Recruiting
- Intensive care unit, Clinique Ambroise ParéVerified postcodeNeuilly-sur-Seine, France· Recruiting
Common questions
What is 'post-resuscitation syndrome'?
It's a serious condition that can happen after someone has had a heart attack and CPR. It means the body's organs, including the brain, are struggling to recover, often due to very low blood pressure.
What are hydrocortisone and AVP?
They are medicines that might help to stabilise blood pressure and support the body's organs and brain after a heart attack and CPR. Hydrocortisone is a type of steroid, and AVP helps regulate blood pressure.
Will I know if I'm getting the study drug or a placebo?
No, this is a 'blinded' study, meaning neither you nor your doctors will know which treatment you are receiving. This helps ensure the results are fair.
How long does the treatment last?
The AVP drip could last up to 3 days, and the hydrocortisone injections would be given for 7 days. Your overall recovery will be monitored for at least 30 days.
Can I stop participating if I change my mind?
Yes, you or your relative can decide to stop participating at any time, and it won't affect the care you receive from the doctors and nurses.
How to find out more
Guillaume GERI, MD, PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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