Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Urea treatment of hyponatremia in subarachnoid hemorrhage

This research is exploring a new way to treat low sodium levels in the blood, a common problem for people who have experienced a type of bleeding stroke called a subarachnoid hemorrhage. The study aims to find out if a medicine called urea can safely and effectively raise sodium levels compared to a dummy medicine (placebo). Researchers will focus on how much sodium levels change during treatment and will also look at how quickly sodium levels improve, the amount of other sodium treatments needed, and if urea helps with a patient's recovery and length of hospital stay. We also want to understand how urea works in the body and check for any side effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Centre Hospitalier Universitaire Grenoble Alpes

Enrolment target

Start

29 Nov 2024

hyponatremia during subarachnoid hemorrhage

What is this study about?

Imagine your body's salts are like ingredients in a recipe – they need to be just right for everything to work well. Sodium is a very important salt. After a specific type of bleeding stroke in the brain, called a subarachnoid hemorrhage, some people can develop very low sodium levels in their blood. This condition is called hyponatremia, and it can cause problems and make recovery harder. Doctors are always looking for better ways to help patients in this situation.

This study, which is in an early stage (Phase II), is testing a medicine called urea. You might have heard of urea as a natural substance in your body, but here it's being used as a potential treatment. The main goal is to see if urea can safely and effectively bring sodium levels back to normal compared to a dummy medicine, called a placebo. A placebo looks just like the real medicine but has no active ingredient; it helps researchers understand if the real medicine is having an effect, or if improvements happen anyway.

Beyond just looking at sodium levels, the study will also explore several other important things. For example, it will check if urea helps reduce how long someone needs to stay in the hospital, if it affects their brain recovery three months after the stroke, and if there are any unwanted side effects. Researchers will also compare how quickly sodium levels improve with urea versus the placebo and try to understand exactly how urea works within the body to correct sodium imbalances. All of this information will help doctors decide if urea could be a valuable treatment in the future.

Key takeaways

This study investigates urea as a treatment for low sodium levels after a bleeding stroke in the brain.
It aims to see if urea is better than a dummy medicine (placebo) at raising sodium levels.
Researchers will also look at whether urea helps with hospital stay duration and brain recovery.
The study will check for any side effects and how urea works in the body.
Both men and women aged 18 and over with this condition may be able to join.

Who may be eligible?

To take part in this study, you would need to be 18 years old or over. There is no upper age limit, meaning people of all adult ages can be considered. Both men and women are welcome to join.

The most important thing is that you must have low sodium levels in your blood, specifically occurring after you have had a subarachnoid hemorrhage – that's a type of bleeding stroke in the brain.

There might be other health conditions or medicines that would mean you couldn't take part, to make sure the study is safe for everyone involved. The study team will check all your medical information carefully to see if this study is right for you.

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?
Have you recently had a subarachnoid hemorrhage (a specific type of bleeding stroke in the brain)?
Have doctors told you that you have low sodium levels in your blood (hyponatremia) because of the stroke?
Are you able to follow study instructions and attend follow-up assessments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be given either the study medicine (urea) or a dummy medicine (placebo). You wouldn't know which one you are receiving. The main part of your participation would involve regularly having your blood sodium levels checked. These checks would happen before you start treatment and continue until the day you stop receiving the study medicine.

Throughout the study, doctors and nurses would carefully monitor your health, including looking at how much sodium you might need through other means, how long you stay in the hospital, and how your brain recovery progresses over about three months. There will also be checks for any side effects you might experience. Some blood tests will also help researchers understand how the urea works. After you stop the study medicine, your sodium levels will be checked again for 48 hours to see if the correction lasts. The total time you'd be involved in the treatment phase of the study would depend on your individual medical needs and how long the doctors decide your treatment should continue.

Potential risks and benefits

Participating in a study like this means you might get a treatment (urea) that could help correct your low sodium levels, potentially leading to a better recovery from your subarachnoid hemorrhage. However, because it's a new treatment in this setting, we don't yet know all its effects, and there's no guarantee it will help you personally. You might experience side effects from the urea, or from other procedures like blood tests. It's important to remember that you can stop taking part in the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is hyponatremia?

Hyponatremia means you have lower than normal levels of sodium, an important salt, in your blood. It can be a problem after a brain bleed.

What is a subarachnoid hemorrhage?

This is a serious type of stroke caused by bleeding on the surface of the brain.

What is a placebo?

A placebo is a dummy medicine that looks like the real thing but has no active ingredient. It helps researchers compare the effects of the actual medicine.

Will I know if I'm getting the real medicine or the placebo?

No, in this type of study, neither you nor your doctors will know if you are receiving urea or the placebo. This helps prevent bias in the results.

How long will I be in the study?

The time you spend receiving the study medicine will vary. Your health and sodium levels will be monitored closely throughout, and your brain recovery assessed for about three months after your stroke.