Efficacy and safety of SP16 in preventing Acute Kidney Injury in at-risk subjects with chronic kidney disease undergoing elective cardiac surgery using the heart-lung-machine: A prospective, randomized, double-blind, placebo-controlled clinical trial (EASE-AKI)
This research study, called EASE-AKI, is exploring a new medicine, SP16, to prevent a serious complication called Acute Kidney Injury (AKI) in certain patients. We're looking for people who already have some kidney issues and are scheduled for heart surgery using a heart-lung machine. AKI is a sudden and severe kidney problem that can occur after major operations. The study will compare SP16 to a placebo (a dummy treatment) to see if SP16 is safe and effective in reducing the risk of AKI. By preventing AKI, we hope to improve recovery and long-term health for these patients after their heart surgery.
At a glance
What is this study about?
When people with existing kidney problems have major heart surgery, there's a risk their kidneys might get damaged, a condition known as Acute Kidney Injury (AKI). This can make recovery harder and lead to longer hospital stays. This study, called EASE-AKI, is testing a new treatment, SP16, to see if it can help prevent this kidney damage. Researchers believe SP16 might protect the kidneys during and after surgery.
Participants in the study will be given either SP16 or a placebo (a treatment with no active medicine) before and after their heart surgery. This is a "double-blind" study, meaning neither the patient nor their doctors will know who is receiving SP16 and who is receiving the placebo. This helps ensure the results are fair and unbiased. The main goal is to see if SP16 can reduce the number of people who develop AKI after surgery.
The study will also look at how safe SP16 is by tracking any side effects. We'll monitor kidney function closely, check how quickly people recover, and look at other aspects of their health for about three months after surgery. The information gathered from this study will help doctors understand if SP16 could become a new way to protect vulnerable patients undergoing heart surgery.
Key takeaways
- This study is testing a new drug, SP16, to prevent kidney damage during heart surgery.
- It's for people who already have some kidney problems and are having heart surgery using a special machine.
- You might receive SP16 or a placebo, and neither you nor your doctors will know which.
- The study will closely monitor your kidney function, overall health, and any side effects.
- Participation lasts about 3 months, including follow-up checks after surgery.
Who may be eligible?
To be considered for this study, you need to be an adult, aged 18 or older. Both men and women are welcome to participate.
You would also need to have a pre-existing kidney condition (chronic kidney disease) and be scheduled for a specific type of heart surgery. This heart surgery must involve the use of a heart-lung machine, and it's typically for problems with heart valves or other cardiovascular issues.
There might be other specific health requirements or conditions that would mean you can't take part, so the study team will review your full medical history to confirm if this study is right for you.
- Are you 18 years old or older?
- Do you have an existing kidney condition (chronic kidney disease)?
- Are you scheduled for heart surgery that uses a heart-lung machine?
- Do you have a heart valve problem or other cardiovascular disease requiring this surgery?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, your journey will involve several visits and assessments. You'll receive either the investigational drug SP16 or a placebo around the time of your heart surgery. The study involves regular checks of your health and kidney function, especially in the days immediately following your operation. This includes blood tests, urine tests, and potentially heart scans (echocardiograms) to see how your heart is doing.
We'll also keep a close eye on any side effects you might experience. After your hospital stay, there will be follow-up appointments, including one about 3 months (90 days) after your heart surgery, to see how you're recovering and to check your long-term kidney and heart health. The total duration of your active participation in the study will be about 3 months.
Potential risks and benefits
Locations (1)
- —Germany
Common questions
What is Acute Kidney Injury (AKI)?
AKI is when your kidneys suddenly stop working as well as they should. It can happen after major surgery and can make you feel very unwell.
What is a placebo?
A placebo is a 'dummy' treatment that looks just like the study drug but contains no active medicine. It helps researchers compare the real drug's effects accurately.
Why is it 'double-blind'?
Double-blind means neither you nor your doctors will know if you're getting SP16 or the placebo. This prevents anyone's expectations from influencing the results.
How long will I be in the study?
Your active participation will be for about 3 months, which includes your surgery, hospital stay, and follow-up appointments.
Will I still get my usual care?
Yes, you will continue to receive the standard medical care for your heart condition during your hospital stay and recovery, alongside the study treatment.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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