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KARMA - INtenSive care TreAtmeNT with adjuvant KetAmine and Recovery after Mechanical ventilAtion: a multicenter doubleblind randomized controlled trial
EU CTIS ID: 2025-523149-80-00
What this study is testing
The primary objective will be to assess recovery from critical illness in patients requiring unplanned invasive mechanical ventilation in the ICU.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • Patients over 18 years of age
- • 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)
- • Need for unplanned invasive mechanical ventilation
- • Need for continuous intravenous sedative agents (propofol, midazolam or dexmedetomidine) for more than 6 hours.
- • Affiliation to a social security system (excluding “Aide Médicale d’Etat” [AME])
You likely can't join if
- • Refusal to participate in the study
- • Début de la ventilation mécanique depuis plus de 48 heures
- • Expected lifespan < 24 hours
- • Patients already receiving a continuous infusion of ketamine
- • 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.
- • Positive highly sensitive pregnancy test
See the full eligibility criteria
- • Patients over 18 years of age
- • 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)
- • Need for unplanned invasive mechanical ventilation
- • Need for continuous intravenous sedative agents (propofol, midazolam or dexmedetomidine) for more than 6 hours.
- • Affiliation to a social security system (excluding “Aide Médicale d’Etat” [AME])
- • Refusal to participate in the study
- • Début de la ventilation mécanique depuis plus de 48 heures
- • Expected lifespan < 24 hours
- • Patients already receiving a continuous infusion of ketamine
- • 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.
- • Positive highly sensitive pregnancy test
- • Psychosis
- • Persons deprived of liberty
- • Persons on a protective judicial measure
- • Severe arterial hypertension ( mean arterial pressure>130 mmHg) despite treatment
- • Hypersensitivity to the active substances or any of the excipients
- • Known contraindications to ketamine according to the SmPC (Severe heart failure, history of stroke, severe uncontrolled hypertension, severe aneurysmal disease, pheochromocytoma)
- • 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)
- • Status asthmaticus
- • Current liver failure with Model for End-Stage Liver Disease (MELD) > 30
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.