Evaluation of hANP for prevention of acute kidney injury after cardiac surgery: A two-part randomized controlled trial with open-label extension in children aged 0–12 months.
This study is testing a medicine called hANP to see if it can prevent kidney damage in babies (up to 12 months old) who have heart surgery. When babies have heart surgery using a heart-lung machine, their kidneys can sometimes get damaged. This study wants to find out if giving a special injection during or after surgery can protect their kidneys and help them work better. The researchers are measuring how well the kidneys clean the blood five hours after the injection. They are also checking how much urine the babies make and how much extra fluid they have in their bodies. This is an early stage study (Phase II) to explore if this medicine works and is safe for these very vulnerable patients.
At a glance
What is this study about?
This study is focused on a very important health issue for babies: kidney problems after heart surgery. When newborn babies and infants up to one year old need surgery for their hearts, especially if doctors use a heart-lung machine during the operation, their kidneys can sometimes struggle afterwards. This is known as acute kidney injury (AKI) and it means the kidneys suddenly stop working as well as they should. Protecting their kidneys is really important for these little ones.
The main goal of this research is to see if a specific medicine, called hANP, can help prevent these kidney problems. Researchers believe this medicine might help the kidneys recover quicker and work better after the stress of a big operation. They want to find out if giving this injection can limit damage and help the kidneys stay healthy during this critical time. This is an exploratory study, meaning it's an early step to understand if the treatment is promising and safe.
The study will look at how well the babies' kidneys are cleaning their blood a few hours after they receive the medicine. They will do this by measuring certain things in blood and urine. They will also keep a close eye on other signs of kidney health, such as how much urine the baby produces and if they are holding onto too much fluid. By carefully checking these things, doctors hope to learn if hANP can make a real difference for these young patients.
Key takeaways
- This study tests a medicine (hANP) to protect babies' kidneys.
- It's for babies under one year old having specific heart surgery.
- Doctors will measure kidney function after the injection.
- The goal is to prevent kidney problems after major heart operations.
- Participation involves extra medical checks and monitoring.
- You can withdraw from the study at any time.
Who may be eligible?
This study is designed for babies who are having heart surgery that involves using a heart-lung machine. It's specifically looking at very young children, from newborns up to 12 months old.
To be considered for the study, a baby must be having this specific type of heart surgery. There are no restrictions based on whether the baby is a boy or a girl. The medical team will carefully review each baby's health to make sure that taking part in the study is appropriate and safe for them.
Your doctor will be able to tell you if your baby meets all the requirements to be included in this research, as there are often specific medical details that need to be checked.
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.
- Is my baby undergoing heart surgery?
- Will a heart-lung machine be used during their surgery?
- Is my baby aged between newborn and 12 months old?
- Has my doctor discussed this study with me?
What does participation involve?
If your baby takes part in this study, they will receive an hANP injection, which is the medicine being tested. This will likely happen around the time of their heart surgery. The doctors and nurses will closely monitor your baby's kidney function by taking regular blood and urine samples. They will measure how well the kidneys are cleaning the blood a few hours after the injection. They will also keep track of things like how much urine your baby produces and how much fluid is in their body for about two days after the surgery.
There might be additional checks of kidney health using special markers in blood and urine over a longer period. The total time your baby is actively monitored for the study's main measurements will be during their hospital stay after surgery, especially the first 48 hours. The medical team will explain all the specific appointments and monitoring steps clearly before you decide to participate.
Potential risks and benefits
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Common questions
What is 'acute kidney injury'?
Acute kidney injury is when the kidneys suddenly stop working properly. In this study, it refers to kidney problems that can happen to babies after heart surgery.
What is hANP?
hANP is the name of the medicine being tested. Doctors want to see if this injection can help prevent kidney damage in babies after heart surgery.
Why are only babies under 12 months old included?
This study focuses on newborns and infants up to 1 year because they are at a higher risk of kidney problems after the type of heart surgery that uses a heart-lung machine.
What is a 'heart-lung machine'?
A heart-lung machine takes over the work of your baby's heart and lungs during surgery, allowing surgeons to operate on a still heart. It's often used in complex heart operations.
Will my baby get extra tests?
Yes, your baby will have specific blood and urine tests to check their kidney function more closely than usual, to help the researchers understand if the medicine is working.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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