The effect of phoSPHocreatine on mEdical emergency team (met) tREated patients: a randomized clinical trial protocol – SPHERE
This study, called SPHERE, is investigating a medicine called Neoton (which contains phosphocreatine) to see if it can help patients who are in a critical condition. These are patients being cared for by a medical emergency team because they have serious issues like breathing trouble, very fast or slow heart rates, very low blood pressure, or a sudden drop in their level of awareness. The researchers want to find out if giving this medicine helps patients live longer and spend more days out of the hospital after 30 days. It's a key stage of research and involves adults aged 18 and older, both men and women, who are facing these medical emergencies.
At a glance
What is this study about?
Imagine someone is suddenly very unwell, perhaps struggling to breathe, their heart beating too fast or too slow, or they've become much less responsive. In hospitals, there's a special team called the Medical Emergency Team (MET) who rush to help these patients quickly.
This study, called SPHERE, is designed to see if a certain medicine, named Neoton Phlebo, can help these very sick patients. Neoton contains a substance called phosphocreatine. Researchers want to understand if giving this medicine to patients who are in a critical condition, and being treated by the MET, can improve their chances of getting better and spending more time at home rather than in the hospital.
The main goal is to measure something called 'days alive and out-of-hospital at day 30'. This means counting how many days a patient is alive and not in the hospital within the first month after they start the study. It helps the researchers see if the medicine makes a real difference to a patient's recovery and well-being.
Key takeaways
- This study is testing a medicine called Neoton for seriously unwell patients.
- It's for adults experiencing emergencies like severe breathing or heart issues.
- The goal is to see if the medicine helps patients live longer and stay out of hospital.
- Participants will receive either the study medicine or a salt water drip.
- All care will be closely monitored by a hospital emergency team.
- It’s a Phase III study, a crucial stage before a medicine can be widely used.
Who may be eligible?
This study is looking for adults who are at least 18 years old. Both men and women can take part.
You would be considered for the study if you are experiencing a serious medical emergency where the hospital's special Medical Emergency Team (MET) has been called to help you. These situations include severe breathing difficulties, heart problems where your pulse is very fast or slow, very low blood pressure, or if you've suddenly become much less responsive or aware.
The medical team will carefully check if your specific condition matches the study requirements before deciding if you can join. They will ensure it's the right fit for you.
- Are you 18 years old or older?
- Are you currently experiencing a serious medical emergency?
- Has the hospital's Medical Emergency Team (MET) been called to treat you?
- Are you willing to potentially receive either the study medicine or a placebo (salt water)?
- Are you happy for your health to be monitored for 30 days after enrolment?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you are eligible and agree to take part, you would receive either the study medicine, Neoton Phlebo, or a saline solution (salt water), given through a drip into your vein. Which one you receive is decided randomly, like flipping a coin. You wouldn't know which one you're getting, and neither would your doctors, to keep the study fair.
The medical team would continue to treat you for your emergency as usual, while also closely monitoring your condition. They would track your progress, how long you stay in the hospital, and your health during the 30 days after you join the study. There might be some follow-up checks during this month to see how you're recovering. The total duration of active follow-up for the study's main outcome would be 30 days.
Potential risks and benefits
Locations (1)
- —Italy
Common questions
What is phosphocreatine?
Phosphocreatine is a natural substance found in your body that helps provide energy to your cells, especially in muscles. The medicine Neoton Phlebo contains this substance.
Why is this study being done?
The study aims to find out if giving phosphocreatine to very sick patients in emergencies can help them recover better and spend more time out of the hospital.
Will I know if I'm getting the real medicine or the placebo?
No, neither you nor your doctors will know if you're receiving the active medicine or the saline solution. This helps ensure the study results are unbiased and reliable.
What is a 'Medical Emergency Team'?
A Medical Emergency Team (MET) is a special team in the hospital that quickly responds to patients who are suddenly becoming very unwell, for example, having trouble breathing or heart problems.
What does 'Phase III' mean for a study?
Phase III means this is a large study to confirm if a new medicine is safe and effective for a specific condition before it can be widely used. It's a key step in approving new treatments.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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