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Could ketamine boost recovery for critically ill patients on ventilators?

NCT ID NCT07590687

Symptom relief Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding low-dose ketamine to standard sedatives helps critically ill patients on breathing machines recover faster and spend more days alive at home. About 640 adults who need unplanned ventilation and sedation will receive either ketamine or a placebo for up to 14 days. Researchers will track outcomes like days at home, brain function, and side effects for 90 days.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 640 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria : 1. Patients over 18 years of age 2. Signed informed consent or inclusion under the emergency provisions of the law (ArticleL1122 -1-3 of the PHC / modified by Order n°2016-800 of June 16 2016 - art. 2) 3. Need for unplanned invasive mechanical ventilation 4. Need for continuous intravenous sedative agents (propofol, midazolam or dexmedetomidine) for more than 6 hours. 5. Affiliation to a social security system (excluding "Aide Médicale d'Etat" \[AME\]) Exclusion Criteria 1. Refusal to participate in the study 2. Acute brain injuries (i.e. acute stroke, traumatic brain injury, cardiac arrest, brain infections) or conditions (status epilepticus or coma with suspected/confirmed intracranial hypertension at admission requiring deep sedation) 3. Psychosis 4. Status asthmaticus 5. Current liver failure with Model for End-Stage Liver Disease (MELD) \> 30 6. Initiation of mechanical ventilation \> 48 hours 7. Expected lifespan \< 24 hours 8. Patients already receiving a continuous infusion of ketamine 9. Currently participating in another interventional clinical trial investigating sedation or protocols using Ketamine or another drug which may interact with Ketamine or which may have an impact on the evaluation of the trial's judgement criteria. 10. Positive highly sensitive pregnancy test 11. Persons deprived of liberty 12. Persons on a protective judicial measure 13. Breastfeeding 14. Severe arterial hypertension (mean arterial pressure\>130 mmHg) despite treatment 15. Hypersensitivity to the active substances or any of the excipients 16. Known contraindications to ketamine according to the SmPC (Severe heart failure, history of stroke, severe uncontrolled hypertension, severe aneurysmal disease, pheochromocytoma)

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Conditions

The condition(s) this trial relates to.

Critical Illness delirium

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Critical illness

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Department of Intensive Care Medicine, APHP.Nord, hôpital Bichat Claude Bernard,

    Paris, 75018, France

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