Preventing oxidative stress-induced ischemic injury and systemic inflammation complications during and after invasive cardiac surgery with alkaline phosphatase (APPIRED III)
This important study, called APPIRED III, is looking for ways to protect patients having major heart surgery that uses a heart-lung machine. Sometimes, this can lead to serious problems like inflammation and kidney damage. Researchers are testing a new drug called RESCAP to see if it can prevent these complications. Patients will either receive RESCAP or a dummy treatment (placebo). The study aims to find out if RESCAP can help patients recover more smoothly and reduce serious risks by reducing stress on the body during and after surgery. This is a crucial step in making heart surgeries even safer.
At a glance
What is this study about?
When you have major heart surgery, especially if doctors use a heart-lung machine, your body can sometimes get very stressed. This stress can lead to problems like inflammation all over the body or even damage to your kidneys. These complications can make your recovery harder and longer. Doctors are always looking for better ways to protect your body during and after these important operations.
This study, called APPIRED III, is testing a new drug called RESCAP. The main goal of RESCAP is to reduce this body stress and inflammation. By doing this, researchers hope it can prevent serious issues like kidney damage and make your recovery from heart surgery smoother. It's a 'Phase III' study, which means it's one of the final steps to see if the drug is truly effective and safe before it might be widely used.
To find out if RESCAP works, some patients will receive the drug, while others will receive a 'placebo.' A placebo looks exactly like the drug but doesn't contain any active medicine. This allows doctors to compare the two groups fairly and really understand if RESCAP is making a difference. The study is very carefully designed with strict rules about when to continue or stop, always prioritizing patient safety and checking if the drug is truly helping without causing significant side effects.
Key takeaways
- This study explores a new drug (RESCAP) to prevent complications after heart surgery.
- It aims to reduce inflammation and protect kidneys during and after major operations.
- Participants will receive either the active drug or a dummy treatment (placebo).
- Close monitoring for safety and effectiveness is a key part of the study.
- The study focuses on improving recovery for patients undergoing heart-lung machine surgery.
- You can stop participating at any time without affecting your medical care.
Who may be eligible?
This study is for adults who are planning to have a specific type of major heart surgery that involves using a heart-lung machine. It’s important that your doctors believe you are healthy enough otherwise to potentially take part in a study like this.
You would need to be at least 18 years old to be considered. Both men and women are welcome to take part in this research.
Other specific medical details will be checked by your care team to make sure this study is right and safe for you, as not everyone undergoing heart surgery will be able to join.
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 scheduled for major heart surgery that requires a heart-lung machine?
- Are you able to understand and agree to the study rules?
- Do you have any other serious health conditions that might prevent you from joining (your doctor will check this)?
What does participation involve?
If you decide to take part in this study, you would receive either the new drug (RESCAP) or a dummy treatment (placebo) during and after your heart surgery. This would be given through a drip into your arm. You wouldn't know whether you're getting the active drug or the placebo, and neither would your doctors, to ensure fair results. Your health will be very closely monitored throughout the process, including checks on your kidney function and general recovery.
Participation would involve your usual hospital stay for heart surgery, with extra monitoring and collection of information as part of the study. After you leave the hospital, there would likely be follow-up appointments, which your study team will explain in detail. The total duration of your participation would cover the time before, during, and after your surgery, including these follow-up checks, which could last for several weeks or months, depending on the study's design.
Potential risks and benefits
Locations (2)
- —UnverifiedBelgium
- —UnverifiedAustria
Common questions
What is a 'placebo'?
A placebo is a dummy treatment that looks exactly like the study drug but doesn't contain any active medicine. It helps researchers fairly compare the new drug's effects.
Will I know if I'm getting the drug or the placebo?
No, neither you nor your doctors will know if you're receiving the drug or the placebo. This helps prevent bias and ensures the study results are accurate.
What kind of heart surgery is this study for?
This study is specifically for major heart surgeries that require the use of a heart-lung machine, which helps your heart and lungs work during the operation.
Can I leave the study if I change my mind?
Yes, you are free to leave the study at any time, for any reason, and it will not affect your medical care in any way.
What if the drug causes problems?
Your safety is the top priority. The study has strict rules to stop if there are too many serious side effects or if the drug appears to be causing more harm than good.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.