RecruitingOBSERVATIONAL

Impact of Post-ARDS Covid-19 Sedation on Persistent Neuroinflammation

This study is for people who had severe COVID-19 and needed a breathing machine in intensive care. Many such patients can develop confusion, known as delirium, which can affect their memory and thinking in the long term. Researchers believe this confusion might be linked to inflammation in the brain. This study wants to find out if a specific calming medicine, called dexmedetomidine, might help protect the brain from this inflammation. They are looking at severe COVID-19 patients who needed breathing support and comparing those who received dexmedetomidine with those who didn't. The goal is to better understand how to protect brain health after critical illness from COVID-19.

At a glance

Status

Recruiting

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

Start

21 Mar 2022

Estimated completion

04 Feb 2026

Severe COVID-19

What is this study about?

When people get very sick with COVID-19, especially if they develop severe lung problems (called Acute Respiratory Distress Syndrome or ARDS), they often need to be in intensive care. This usually means they'll need a machine to help them breathe (a ventilator) and strong calming medicines, sometimes for a long time. The medical team tries to help them off the breathing machine as soon as safely possible.

Unfortunately, a common problem for about 60% of these patients is experiencing a period of severe confusion, known as delirium, while they are coming off the breathing machine. Delirium can be very distressing and can sometimes lead to serious problems during their hospital stay. Even after leaving the hospital, about 30% of people who had delirium in intensive care continue to have some difficulties with their memory, thinking, or concentration. Scientists think that serious inflammation in the brain might be a key reason why delirium happens and leads to these longer-term issues.

This study is looking into a particular calming medicine called dexmedetomidine. Besides helping people relax, early research suggests that this medicine might also help protect the brain by reducing inflammation. Researchers want to see if dexmedetomidine can help lessen brain inflammation and improve long-term thinking abilities in people who have recovered from severe COVID-19. They are comparing patients who received this medicine with those who didn't, to understand its potential benefits.

Key takeaways

Severe COVID-19 can lead to delirium and long-term thinking problems.
Brain inflammation might be a cause of these issues.
This study explores if dexmedetomidine, a calming medicine, helps protect the brain.
It focuses on patients who had severe COVID-19 and needed breathing support.
The research aims to improve care for future critically ill COVID-19 patients.

Who may be eligible?

This study is looking for adults aged 18 to 74 years old who have previously been very sick with COVID-19. To be included, you must have had a confirmed COVID-19 infection and needed a breathing machine and strong calming medicines in intensive care for at least 24 hours because of severe lung problems (ARDS).

If you took part in this study, you would need to be alive 24 months after being discharged from intensive care. There's also a specific genetic test related to brain inflammation that you would need to have a certain result for us to include you. If you were given dexmedetomidine for at least 24 hours during your intensive care stay, you would be part of one group; if you didn't receive it, you would be in another comparison group.

However, some people cannot take part. This includes if you are pregnant or breastfeeding, if you have certain existing serious brain conditions like a stroke or severe head injury, or if you have severe kidney problems. You also cannot be included if you cannot have special brain scans (PET or MRI) or if you are legally unable to make your own decisions (for example, living under guardianship).

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 between 18 and 74 years old?
Did you have a confirmed COVID-19 infection?
Were you in intensive care for severe COVID-19 (ARDS) and needed a breathing machine for at least 24 hours?
Are you able to have brain scans (PET and MRI)?
Do you have a specific genetic test result related to brain inflammation (TSPO genotyping)?
Do you have any serious brain conditions like a history of stroke or severe head trauma?

Answer every question to see your result.

What does participation involve?

The description implies that this study is mainly looking at existing medical records and possibly conducting assessments on patients who have already recovered. It particularly mentions being alive 24 months after discharge from intensive care, which suggests it's a look-back study or involves follow-up assessments long after the initial illness.

There is no clear indication of specific visits or medication administration as part of the study; it seems to be studying the effects of medication already given during intensive care. The study aims to evaluate brain inflammation using special scans, but it's not explicitly stated if these scans would be scheduled specifically for the study participants. The total duration of your participation, and the exact number or type of assessments, are not fully detailed in the provided information.

Potential risks and benefits

Participating in research studies like this can help doctors better understand severe COVID-19 and its effects on brain health, potentially leading to improved care for future patients. There might not be direct personal health benefits from taking part, as this study mainly looks at past treatment and long-term effects. The information provided doesn't detail specific risks associated with participation beyond potential risks from brain scans if they are part of the study. You would always have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

Anesthesy department - Hôpital Pitié Salpêtrière
Verified postcode
Paris, France· Recruiting

Common questions

What is ARDS?

ARDS stands for Acute Respiratory Distress Syndrome. It's a severe lung injury that makes it very hard to breathe and often requires a breathing machine in intensive care.

What is delirium?

Delirium is a state of severe confusion that can happen to people who are very ill, especially in intensive care. It can affect attention, thinking, and awareness of surroundings.

What is dexmedetomidine?

Dexmedetomidine is a type of calming medicine used in hospitals, particularly in intensive care, to help patients relax and sleep.

What is neuroinflammation?

Neuroinflammation means inflammation within the brain. Researchers believe it might play a role in the confusion (delirium) and long-term thinking problems experienced by some very ill patients.

Will I receive new treatment in this study?

Based on the description, this study seems to be looking at the effects of treatments you may have already received during your intensive care stay for COVID-19, rather than giving new treatments.

How to find out more

Vincent DEGOS, Pr

vincent.degos@aphp.fr (0)1 42 16 37 61 Official trial record

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