Study of ketamine hydrochloride to improve recovery in adults requiring unplanned mechanical ventilation in the intensive care unit

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What is this study about?

This study focuses on patients in the Intensive Care Unit (ICU) who require unplanned invasive mechanical ventilation, which is a method of using a machine to help a person breathe. The goal of the study is to assess recovery from critical illness in these patients. The research compares the effects of using ketamine hydrochloride, an injectable medication, against a placebo.

Participants will receive either an infusion, which is a continuous flow of medicine through a vein, of the test medication or a sodium chloride solution. During the study, various health factors are monitored, including the use of norepinephrine or inotropes, which are medications used to support blood pressure and heart function. The study also looks at the presence of encephalopathy, a term used to describe changes in brain function such as coma or delirium, as well as the impact on kidney and liver health.

The course of the study involves tracking recovery over a period of several months. This includes monitoring the use of opioids and sedatives, which are medicines used to manage pain and sleep, and observing symptoms such as hallucinations, anxiety, depression, or post-traumatic stress disorder (PTSD). Information is collected to see how many days patients spend alive and at home, as well as how long they can breathe without the help of a machine.

Who Can Join the Study?

  • You must be an adult, which means you are 18 years of age or older.
  • You or your legal representative must provide informed consent, which is a formal agreement to participate in the study after being told about its details. In certain emergency situations, specific legal rules may allow participation.
  • You must require unplanned invasive mechanical ventilation. This means you need a machine to help you breathe through a tube that was placed in your airway unexpectedly.
  • You must be in the ICU, which is the Intensive Care Unit, a special hospital area for patients who need very close monitoring and constant care.
  • You must need continuous intravenous sedative agents for more than 6 hours. This means you are receiving medicine through a vein to make you feel calm or sleepy, such as propofol, midazolam, or dexmedetomidine.
  • You must have social security affiliation, meaning you are covered by a government health insurance system, but this excludes those covered only by Aide Médicale d’Etat (AME).

Who Cannot Join the Study?

  • You do not want to take part in the study.
  • You have already been using a machine to help you breathe, known as invasive mechanical ventilation, for more than 48 hours.
  • It is expected that your life expectancy is less than 24 hours.
  • You are already receiving a continuous drip of ketamine, which is a medication used to induce sedation or pain relief.
  • You are currently taking part in another medical study that uses sedation (medicine to make you sleepy or unconscious) or drugs that could interfere with how this study is measured.
  • A pregnancy test shows that you are pregnant.
  • You have psychosis, which is a mental health condition that affects how a person thinks, feels, or behaves.
  • You are currently in a situation where your freedom is restricted, such as being in prison.
  • You are under a protective judicial measure, which is a legal arrangement made by a court to protect your interests.
  • You have severe arterial hypertension, which is very high blood pressure, specifically when your mean arterial pressure (the average pressure in your arteries during one way of the heart beating) stays above 130 mmHg despite taking medicine.
  • You have an allergy or hypersensitivity to the active ingredients or any of the excipients (the inactive substances used to make a medicine).
  • You have medical reasons why you cannot take ketamine, such as severe heart failure (the heart cannot pump enough blood), a history of stroke (interruption of blood flow to the brain), uncontrolled high blood pressure, aneurysmal disease (weakened, bulging spots in blood vessels), or pheochromocytoma (a type of tumor on the adrenal gland).
  • You have acute brain injuries, such as a sudden stroke, a traumatic brain injury from an accident, a cardiac arrest, or an infection in the brain.
  • You have conditions like status epilepticus (a seizure that lasts too long) or being in a coma with suspected high pressure inside the skull that requires deep sedation.
  • You are experiencing status asthmaticus, which is a severe, sudden attack of asthma that does not respond to standard treatments.
  • You have liver failure, which is when the liver cannot function properly, with a score higher than 30 on the MELD scale (a tool used by doctors to measure the severity of liver disease).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Clinique Pasteur Toulouse France
Centre Hospitalier Universitaire De Lille Lille France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier Victor Dupouy Argenteuil France
Centre Hospitalier Le Mans Le Mans France
Centre Hospitalier Universitaire De Rennes Rennes France
Hopital Beaujon Clichy France
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Azypzboqmn Pnnzjqzm Hieyjmxj Dz Mqktdcygk Marseille France
Cpjd Dy Nurxy Vandoeuvre Les Nancy France
Hhjdwurs Uicytnsqxpybvn Sdrppulkdf &sptwie Hgixvuq df Hgbjgxzqhnt STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
30.09.2026

Trial locations

Ketamine is a medication given through an IV drip that is used in this study to see if it helps patients recover better after being on a breathing machine in the intensive care unit.

Investigated diseases:

Critical illness – This condition occurs when an organ or system fails to function properly, often following a severe injury or infection. It can involve the respiratory, cardiovascular, or neurological systems. As the condition progresses, the body may struggle to maintain basic physiological processes, such as breathing or blood pressure. This often necessitates intensive medical support to maintain vital functions.

Trial ID:
2025-523149-80-00
Protocol code:
APHP240938
Trial Phase:
Therapeutic use (Phase IV)

Other Trials to Consider

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    Investigated drugs:
    France