Fluid-responsiveness Assessment Simplified by Electric Cardiometry in Children
This study aims to find a quicker, easier, and non-invasive way to tell if critically ill children with heart problems or shock need more fluids. Doctors often give fluids to help, but too much can be harmful. This new test uses a gentle press on the child's tummy and a special device (electrical cardiometry) to measure changes in heart function. If the test shows that fluids would likely improve their condition, doctors can then give them, avoiding giving fluids unnecessarily. The study will check how well this new test predicts if a child will benefit from extra fluids, making it safer and more effective for young patients.
At a glance
What is this study about?
When children are very ill, sometimes their bodies can't get enough blood flowing properly, a condition called circulatory failure or shock. A common way doctors try to help is by giving extra fluids, like an IV drip. However, giving too many fluids can also be harmful, leading to problems like fluid overload, which can make a child's condition worse. So, it's really important for doctors to know if a child will truly benefit from more fluids before they give them.
Currently, some tests are complicated or take a long time. This study is exploring a new, simpler approach. It involves gently pressing on a child's tummy – a bit like a doctor might do during a check-up – which temporarily increases blood flow to the heart. A special, non-invasive monitor called electrical cardiometry then measures how the heart responds to this gentle pressure. The idea is that if the heart's pumping improves significantly after this tummy press, it suggests the child would likely benefit from more fluids.
The main goal is to see if this new, quicker, and easier test can accurately predict which critically ill children will genuinely get better with more fluids, and which ones won't. If successful, this could help doctors make better decisions, providing fluids only when they are truly needed, and avoiding potential harm from giving too much.
Key takeaways
- The study tests a new, simpler way to decide if sick children need IV fluids.
- It aims to prevent giving too much or too little fluid.
- The test involves a gentle tummy press and a special heart monitor.
- It's for children aged 0 days to 8 years in intensive care.
- Participation will be integrated into the child's existing medical care.
- The goal is quicker, safer decisions for children's fluid management.
Who may be eligible?
This study is looking for babies and children up to 8 years old who are currently in a children's intensive care unit. For them to join, their doctor must have decided they need an IV fluid top-up because of problems with their circulation.
Also, a specific type of heart monitor called electrical cardiometry must already be in use as part of their routine care. If a child is too unstable for any delay, has certain stomach conditions, can't lie flat, or if doctors can't get a clear ultrasound, they wouldn't be able to join.
Very premature babies (born before 37 weeks, and still at that stage) or those whose parents don't want them to participate also can't be included. The child or parent has the final say on whether to take part.
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 child 8 years old or younger?
- Is my child in a children's intensive care unit?
- Has my child's doctor prescribed an IV fluid top-up?
- Is electrical cardiometry already being used to monitor my child?
- Does my child have any severe tummy pain or recent tummy surgery?
- Can my child lie flat without issues?
What does participation involve?
As this study involves critically ill children, the tests would be incorporated into their existing care in the intensive care unit. Taking part would involve the child receiving the gentle tummy compression maneuver, while a non-invasive monitor (electrical cardiometry), which might already be in use, records their heart's activity. At the same time, an ultrasound of the heart would be performed, which is a standard procedure in intensive care. The study aims to see how well these measurements predict if giving an IV fluid top-up (which the doctor has already decided is needed) will help the child. There are no additional medications given specifically for the study. The total duration of participation would be during the period when their doctor has prescribed the fluid top-up.
Potential risks and benefits
Locations (4)
- Hôpital Marie LannelongueVerified postcodeLe Plessis-Robinson, France· Not yet recruiting
- Hôpital Arnaud de Villeneuve - CHU de MontpellierVerified postcodeMontpellier, France· Not yet recruiting
- Hôpital mère-enfant - CHU de NantesVerified postcodeNantes, France· Not yet recruiting
- Hôpital Cardiologique Haut Lévêque - CHU de BordeauxVerified postcodePessac, France· Recruiting
Common questions
What is 'circulatory failure'?
It means the body isn't getting enough blood flow, which can affect how organs work.
It's about whether giving a child extra fluids will actually improve their blood flow and condition.
Is the tummy press painful?
It's described as a 'gentle' press, not expected to be painful, and aims to be temporary and reversible.
What is electrical cardiometry?
It's a non-invasive device that measures how well the heart is pumping, usually by placing small pads on the skin.
Will my child get extra medication?
No, the study doesn't involve giving any new or extra medications. It focuses on testing a way to decide if fluids, which the doctor has already prescribed, will be helpful.
How to find out more
Julien GOTCHAC, MD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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