RecruitingPHASE2INTERVENTIONAL

Efficacy of Early Intravenous High-dose Vitamin C in Post-cardiac Arrest Shock.

This study is investigating if early treatment with high-dose vitamin C (Laroscorbine) and vitamin B1 (Bevitine) can help patients who develop a serious condition called 'shock' after a cardiac arrest outside of hospital. Cardiac arrest is when the heart suddenly stops beating. After the heart is restarted, many patients develop shock, which means their body isn't getting enough blood, leading to organ damage and sometimes death. Previous research suggests vitamin C might help reduce inflammation and protect blood vessels. This study, involving 234 patients, compares those who receive the vitamins plus standard care to those who only receive standard care, to see if the vitamins can improve recovery over 28 days.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Centre Hospitalier de Bethune

Enrolment target

234

Start

27 Dec 2023

Estimated completion

24 Jan 2028

Cardiac Arrest

What is this study about?

Heart attacks are a scary medical emergency where your heart suddenly stops pumping. Even after doctors successfully restart the heart, many patients can develop a serious complication called 'shock.' This shock means the body isn't getting enough blood and oxygen to its vital organs, which can cause them to fail. Sadly, this can lead to patients becoming very unwell, and sometimes even death.

Researchers are very interested in finding ways to help these patients recover. There's some early evidence from lab studies and other medical research that a high dose of vitamin C – given directly into the bloodstream – might help. It's thought that vitamin C could reduce inflammation and protect blood vessels, which are both important issues during shock. There are also ideas that it might help protect the brain and other organs and improve overall recovery.

This study, called a 'Phase 2' trial, aims to see if adding these vitamins to the usual medical care makes a difference. It's a controlled study, meaning some patients will get the vitamins along with standard care, and others will just get standard care. By comparing these two groups, doctors hope to understand if this vitamin treatment is effective and safe for people experiencing shock after a heart attack. The results will help guide future treatments for these vulnerable patients.

Key takeaways

This study is for patients experiencing 'shock' after a heart attack outside of hospital.
It tests if early high-dose Vitamin C and B1 can improve recovery.
Patients will be randomly assigned to receive vitamins plus standard care, or just standard care.
The study aims to enrol 234 patients and lasts for 28 days per patient.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for adults aged 18 or over who have had a heart attack outside of hospital and are still unconscious (in a coma) even after their heart has been restarted. To be considered, patients must also be receiving medication to help maintain their blood pressure due to shock.

There are several reasons why someone might not be able to join the study. This includes if their heart attack was clearly caused by an injury, bleeding, or poisoning, rather than a heart problem itself. Patients cannot join if they have certain kidney problems (like kidney stones or severe kidney disease), or a rare inherited condition where their body stores too much iron (hemochromatosis) or a specific enzyme deficiency (G6PD deficiency). Also, if a patient is already receiving vitamin C treatments, has a known lack of vitamin C, or is taking part in another medical study, they won't 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?
Did you have a heart attack outside of hospital?
Are you currently unconscious (in a coma) after your heart was restarted?
Are you receiving medication to keep your blood pressure stable due to shock?
Do you have severe kidney disease, certain kidney stone issues, or specific genetic conditions?

Answer every question to see your result.

What does participation involve?

If you are eligible and agree to take part in this study, you will be randomly placed into one of two groups. Neither you nor your doctor will get to choose which group you are in. One group will receive high doses of Vitamin C and Vitamin B1 directly into their bloodstream, in addition to the usual care for shock. The other group will receive only the standard care. The vitamins would be started as soon as possible, within an hour of joining the study, and Vitamin B1 would be given every 12 hours for 3 days.

The study will follow your progress for 28 days. During this time, doctors and nurses will monitor you closely as part of your normal care in the intensive care unit. They will be looking at how well you are recovering from the heart attack and shock. The entire study aims to recruit 234 patients over 2 years.

Potential risks and benefits

While we hope this study will show that Vitamin C and B1 are helpful for patients recovering from a heart attack and shock, it's important to remember that the benefits are not guaranteed. There's a chance the vitamins might not make a difference, or very rarely, they could cause unexpected side effects, even though previous studies generally suggest high-dose vitamin C is safe. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (14)

Centre Hospitalier Universitaire d'Amiens
Verified postcode
Amiens, France· Active not recruiting
CH d'Arras
Verified postcode
Arras, France· Recruiting
Centre Hospitalier Béthune
Verified postcode
Béthune, France· Recruiting
CHI Nord-Ardennes
Verified postcode
Charleville-Mézières, France· Active not recruiting
Centre Hospitalier de Dieppe
Verified postcode
Dieppe, France· Recruiting
GHEF Site Marne La Vallée
Verified postcode
Jossigny, France· Recruiting
Centre Hospitalier de LENS
Verified postcode
Lens, France· Recruiting
Centre Hospitalier Universitaire de LILLE
Verified postcode
Lille, France· Recruiting
CH de Melun (GHSIF)
Verified postcode
Melun, France· Active not recruiting
Hôpital Lariboisière
Verified postcode
Paris, France· Recruiting
Centre Hospitalier de Rouen
Verified postcode
Rouen, France· Recruiting
Centre Hospitalier Toulon La Seyne sur Mer
Verified postcode
Toulon, France· Recruiting

Common questions

What is 'shock' after a heart attack?

Shock after a heart attack means your body isn't getting enough blood and oxygen to its main organs, causing them to struggle and potentially fail.

Why are vitamins being tested?

Early research suggests that high doses of vitamin C might help reduce inflammation and protect blood vessels, which are key problems during shock, potentially aiding recovery.

Will I know if I'm getting the vitamins or standard care?

No, you will be randomly assigned to one group, and your doctors will not know which treatment you are receiving to ensure the study is fair and unbiased.

How long will I be involved in the study?

Your participation in the study will last for 28 days, during which your recovery will be closely monitored.

Can I stop being part of the study once I've started?

Yes, you can choose to stop participating in the study at any point, and this will not affect your medical care.

How to find out more

Jonathan CHELLY

jonathan.chelly@ch-toulon.fr 04.94.14.51.24 Official trial record

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