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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 trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>medication administration</b>

    After joining the study, an infusion, which is a continuous delivery of liquid through a vein, is started.

    One group receives ketamine hydrochloride at a dose of 14.4 mg/kg (milligrams per kilogram of body weight) via infusion.

    Another group receives sodium chloride, which is a placebo (a substance with no active medicine), via infusion at a dose of 0 mg/h.

  2. Step 2

    <b>monitoring and evaluation</b>

    During the first 14 days, assessments are made regarding pain, sedation (levels of sleepiness or calmness), and hallucinations.

    The amount of opioids (pain-relieving medicines) and sedatives (medicines used to induce sleep or calm) used is recorded during this 14-day period.

    The presence of encephalopathy, which refers to coma or delirium (a state of confusion), is monitored during these 14 days.

  3. Step 3

    <b>recovery follow-up</b>

    At 60 days after the start of the medication or placebo, the number of days spent alive and at home is recorded.

    At 60 days, the number of days spent alive without the use of mechanical ventilation (a machine that helps with breathing) and without vasopressors (medicines used to raise blood pressure) is assessed.

    At 60 days, measurements are taken regarding kidney toxicity and liver toxicity.

    At 90 days, the prevalence of death from any cause is recorded.

    At 90 days, assessments for anxiety, depression, and posttraumatic stress disorder (a condition caused by experiencing a traumatic event) are performed.

Who can join the trial?

6 criteria

  • 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 trial?

16 criteria

  • 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).
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Investigated drugs

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.

What is already known about the treatment

  • SODIUM CHLORIDE

    This substance is administered as an intravenous infusion, meaning it is delivered directly into the bloodstream through a tube. It is a common salt solution widely used in hospitals to maintain fluid balance and as a base for other medications. In this study, it serves as a placebo, which is an inactive substance used for comparison.

  • KETAMINE HYDROCHLORIDE

    This medication is given as an injection through an intravenous infusion into the bloodstream. It is a well-established drug used in medical settings for sedation and pain relief during various procedures. It works by blocking specific chemical messengers in the brain that transmit pain signals, effectively calming the central nervous system. This drug is classified as a dissociative anesthetic.

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2025-523149-80-00Protocol codeAPHP240938Estimated enrolment640 patientsSponsorAssistance Publique Hopitaux De Paris

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