RecruitingOBSERVATIONAL

Diagnostic Performance of the Mitral Annulus Velocity Variation Measured by Tissue Doppler to Evaluate the Fluid Responsiveness During the Initial Management of Shock in Patients Admitted to the Emergency Department

Doctors often need to quickly decide if giving fluids will help patients who are in a serious condition called shock. It can be tricky to tell if the fluids are actually working. This study is testing a new, simpler way to do this using a type of ultrasound. Researchers are looking at how a specific measurement from the heart, called the E' (E-prime) velocity, changes before and after a patient receives fluids. If this measurement reliably shows that fluids are helping, it could give doctors a quicker and easier tool to make treatment decisions in the emergency department, potentially improving patient care for those experiencing shock.

At a glance

Status

Recruiting

Sponsor

Centre Hospitalier Universitaire de Nīmes

Enrolment target

187

Start

01 Aug 2023

Estimated completion

31 Dec 2026

Shock

What is this study about?

When someone is in 'shock', it means their body isn't getting enough blood flow to its vital organs. This is a very serious medical emergency. Doctors often give fluids into a vein (called 'vascular filling') to try and improve blood flow. However, it's not always clear if giving these fluids will actually help or if another treatment is needed.

Currently, some methods used to see if fluids are working can be difficult or time-consuming to perform in a busy emergency room. This study is exploring a new, easier way to check this using a special type of ultrasound scan of the heart. The ultrasound looks at a specific measurement called the 'mitral annulus velocity' (E'). Previous research suggests this measurement is sensitive to how much fluid is in a patient's body.

The main aim of this study is to see if changes in this E' measurement, before and after a patient receives fluids, can accurately predict if the fluid treatment is going to be successful. If it proves to be a good and reliable indicator, it could provide doctors with a much-needed tool to quickly and effectively guide treatment for patients in shock in the emergency department.

Key takeaways

Tests a new way to see if fluids help patients in shock.
Uses a simple heart ultrasound measurement (E').
Aims to give doctors a faster treatment guide.
Does not change your planned medical care.
Participation involves two quick ultrasound scans.

Who may be eligible?

To join this study, people need to be at least 18 years old and have a serious condition called shock, where their blood pressure is quite low (below 65 mmHg). The doctors caring for them must have already decided that giving 500ml of fluids through an IV is the right next step for their treatment.

There are also some important reasons why someone couldn't join. For example, if they've already received two fluid treatments for their current shock, or if their shock is caused by a problem with their heart itself, they wouldn't be able to participate. Also, patients who have certain brain conditions, are on a breathing machine before getting fluids, or are pregnant or breastfeeding cannot take part. If a patient is under court protection, they also can't be included.

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 currently in shock with low blood pressure?
Has your doctor decided to give you IV fluids (500ml)?
Have you had fewer than two fluid treatments for this shock already?
Are you not pregnant, breastfeeding, or on a breathing machine before fluids?

Answer every question to see your result.

What does participation involve?

If you join this study, doctors will take a special ultrasound measurement of your heart before you receive the 500ml of fluids that your main doctor has already planned for you. After you've had those fluids, they will take the same ultrasound measurement again. This helps the study team see how your body responds to the fluid treatment. Your participation involves these two ultrasound measurements and does not change the standard medical care you would otherwise receive for your shock. The total duration of your involvement would be very short, focused solely on these measurements during your initial emergency treatment.

Potential risks and benefits

The main benefit of this study is that it might help doctors find a faster and more accurate way to treat patients in shock in the future. For you personally, there is no direct medical benefit as the study only involves measurements and doesn't change your planned treatment. The risks are very low, as the ultrasound is a safe and common procedure. You will receive the same care you would have otherwise, and the measurements add no additional medical products or drugs. Remember, you can choose to stop participating in the study at any time without it affecting your medical care.

Locations (1)

CHU de Nîmes
Verified postcode
Nîmes, France· Recruiting

Common questions

What is 'shock'?

Shock is a serious medical condition where your organs aren't getting enough blood flow, leading to low blood pressure and other problems.

What is an ultrasound?

An ultrasound uses sound waves to create live pictures from inside your body, similar to how baby scans work.

Will this study change my treatment?

No, you will receive the exact same treatment for your shock that your doctors have already planned for you, regardless of your participation.

Is the ultrasound painful?

No, an ultrasound is generally painless. A gel is applied to your skin, and a small device is moved over the area being examined.

How long will my part in the study take?

Your involvement will be very short, just the time it takes to do two quick ultrasound measurements before and after you receive fluids.

How to find out more

Laura GRAU MERCIER, MD

laura.merciergr@gmail.com +33675169725 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.