Critical IllnessPhase 3KARMANCT07590687
KetAmine and Recovery After Mechanical VentilAtion ( KARMA )
A Phase 3 study testing Intervention Group in people with Critical Illness, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Invasive mechanical ventilation of critically ill patients in the intensive care unit (ICU) is associated with significant morbidity and mortality, as well as a severe prognosis in survivors, in terms of functional, psychological, and cognitive sequelae. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Intervention Group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 640 participants
- Where
- 1 siteFrance
- Study dates
- 19 Oct 2026to 19 Jan 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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])
Who cannot join
- Refusal to participate in the study
- 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)
- Psychosis
- Status asthmaticus
- Current liver failure with Model for End-Stage Liver Disease (MELD) > 30
- Initiation of mechanical ventilation > 48 hours
Show all 16Show fewer
- 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
- Persons deprived of liberty
- Persons on a protective judicial measure
- Breastfeeding
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Matthieu Prof LEGRAND, M.D., Ph.D. contact
France1 site
Department of Intensive Care Medicine, APHP.Nord, hôpital Bichat Claude Bernard,
Paris, 75018
Romain Prof SONNEVILLE, MD-PHD, 1 40 25 61 39 ext. 0033, romain.sonneville@aphp.fr
About this study
Official title: Intensive Care Treatment With Adjuvant KetAmine and Recovery After Mechanical ventilAtion: a Multicenter Doubleblind Randomized Controlled Trial.
Invasive mechanical ventilation of critically ill patients in the intensive care unit (ICU) is associated with significant morbidity and mortality, as well as a severe prognosis in survivors, in terms of functional, psychological, and cognitive sequelae. During the initial phase, invasive mechanical ventilation aims to promote oxygenation and reduce respiratory effort, with most patients receiving continuous intravenous sedation comprising gamma-aminobutyric acid (GABA) agonists (propofol, midazolam), and opioids. This continuous intravenous sedation is associated with complications, particularly hemodynamic issues (e.g., hypotension, vasopressor dependency), and neurological concerns (e.g., coma, delayed awakening, withdrawal syndrome upon discontinuation of sedation) during the acute phase and is linked to prolonged mechanical ventilation and long-term neurocognitive sequelae.
The use of ketamine as an alternative sedative agent in ICU has garnered considerable attention in recent years. Ketamine has a rapid onset of action and a short duration of effect, potentially beneficial bronchodilatory effects, and minimal impact on hemodynamics or respiratory drive. It also provides effective analgesia. Due to its action on N-methyl-D-aspartate (NMDA) glutamatergic receptors, its mechanism of action differs from other commonly used agents such as propofol and benzodiazepines. Furthermore, emerging research suggests that ketamine may have anti-inflammatory/immunomodulatory and neuroprotective properties that could be advantageous in critically ill patients.
Read more
Recent observational studies utilizing low-dose ketamine have suggested an improvement in neurological complications in ICU (e.g., coma, delirium) while other authors have raised concerns about potential renal and hepatic toxicity associated with high doses of ketamine used for sedation. Despite its increasing use, there is currently a lack of high-quality data on the efficacy and safety of ketamine use for sedation in critically ill patients.
In this trial, we hypothesise that, critically ill patients requiring unplanned invasive mechanical ventilation, adjunctive treatment with low dose of ketamine will translate into better outcomes, with higher numbers of days alive outside of the hospital.
The study is a multicenter, randomised, double-blinded placebo-controlled superiority trial involving adult patients requiring unplanned mechanical ventilation, and sedation for more than 6 hours in the ICU. Patients will be randomised within 48 hours following initiation of mechanical ventilation adhering to a 1:1 allocation of ketamine or placebo.
Patients will be randomized to receive either intravenous ketamine or placebo as an adjunctive sedative agent during ICU stay for a maximum duration of 14 days.
Follow-up visits will be performed at day 3, day 14, ICU discharge, day 60, and day 90 after randomization.
The primary endpoint, "days alive and at home," will be assessed at day 60. The end of the research visit is the day 90 follow-up visit. If the patient has been discharged from the hospital, the day-90 visit will consist of telephone contact with the patient by a centralized research assistant and he also will complete the scales at D90.
Data collected by phone consist in Vital status, scales's results and Retrieval of Adverse Events if the patient has been discharged home or with the medical team of the healthcare structure if the patient has been discharged to another structure.
Read the detailed description
Phase III study Prospective, multicenter, superiority, double-blind, randomized controlled study with two arms (1:1).
The study includes a screening/baseline visit (V0), followed by daily assessments during the intervention period (V1 to V4), and post-discharge (V5) follow-up visits at Day 60 (V6) and Day 90 (V7).
At screening and baseline (within 48 hours prior to Day 1), eligibility is confirmed, and informed consent is obtained when possible. In cases where prior consent cannot be obtained, deferred consent procedures are applied in accordance with French legislation. Baseline data include medical history, comorbidities, concomitant treatments, clinical examination, and pregnancy testing when applicable.
Randomization is performed at Day 1 (V1). From Day 1 to Day 14 (V4), patients will be receive either intravenous ketamine or placebo as an adjunctive sedative agent during ICU stay for a maximum duration of 14 days.
Until ICU discharge (V5), patients undergo daily assessments including clinical examination, vital status, organ dysfunction (Sequential Organ Failure Assessment [SOFA] score), At Day 14 (V4), opioid and sedative consumption during the treatment period will be quantified.
At Day 60 (V6), ventilator-free days and vasopressor-free days will be assessed.
Duration of delirium and coma are assessed using the RASS/CAM-ICU, at V 4, during the first 14 days following randomization.
Biological monitoring includes daily measurement of serum creatinine and liver function parameters (ASAT, ALAT, gamma-GT, and bilirubin) to evaluate potential renal and hepatic toxicity. Adverse events are collected throughout the ICU stay, and assessed at Day 60 (V6) At ICU discharge (V5), a clinical evaluation and morbidity/mortality assessment are performed if the patient is still hospitalized.
The primary endpoint-the number of days alive and at home-is assessed at Day 60. Secondary outcomes, including mortality (all-cause deaths), are assessed at both Day 60 (V6) and Day 90(V7).
- Conditions
- Critical Illness
- Being tested
- Intervention Group, Placebo
- Keywords
- Ketamine, Critical illness, Intensive care unit (ICU), Mechanical ventilation, Sedation, Delirium
- Medical subject headings
- Critical Illness, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine ® is supplied in 250 mg/5 ml vials containing sterile solution for dilution in sodium chlorure 0.9% for infusions.
PlaceboDrug
Placebo : NaCl 0.9% (vials)
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Ketamine will be started at a dose of 0.2 mg/kg/hour for 4 hours and then adjusted as necessary (+/-0.1 mg/kg/hour every 4 hours) from 0 to 0.6 mg/kg/hour to maintain a targeted RASS of -1 to 0, in addition to standard per local sedation and pain protocols.
Duration of treatment: 14 days in maximum Receives: Drug: Intervention Group |
| Control group | Placebo comparator | Intravenous placebo will be started at a dose of 0.2 mg/kg/hour for 4 hours and adjusted as necessary (+/-0.1 mg/kg/hour every 4 hours) from 0 to 0.6 mg/kg/hour to maintain a targeted RASS of -1 to 0, in addition to standard sedation per local protocol.
Duration of treatment : 14 days in maximum Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days patients are alive and spent at home
This endpoint will be collected by an independent research assistant, blinded to randomization groups, , and not involved in data monitoring onsite.
Measured: At 60 days after ketamine initiation
Secondary outcomes (10)
Number of days alive free of encephalopathy
Number of days spent alive without coma or delirium measured on the CAM-ICU
Measured: During 14 days after randomization
number of days spent alive without invasive mechanical ventilation
ventilation-free days
Measured: At day 60
Number of days spent alive without infusion norepinephrine infusion during ICU stay
Vasopressors-free days
Measured: At day 60
Mortality
Defined by the prevalence of all-cause deaths
Measured: At Day 60 et Day 90
Renal toxicity,
Defined by the proportion of patients with a KDIGO stage ≥2
Measured: At Day 60
Liver toxicity
Defined by the highest bilirubin and phosphatase alkaline level
Measured: At Day 60
Quantification of opioid and sedative consumption
During the treatment period, in each arms during the first 14 days
Measured: Within the 14 days after randomization
Mean daily pain (BPS)
Mean daily Behavioral Pain Scale (BPS) score assessed during the first 14 days.
Measured: During the first 14 days after randomisation
Cumulative incidence of hallucination events
Measured: During 14 days after randomization
Mean daily sedation score (RASS)
Mean daily Richmond Agitation-Sedation Scale (RASS) score assessed during the first 14 days.
Measured: During the first 14 days after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start19 Oct 2026 (estimated)
- Primary completion19 Dec 2029 (estimated)
- Study completion19 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two study groups will be formed: one will receive intravenous ketamine, while the other will receive an intravenous placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Romain Prof SONNEVILLE, MD-PHD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07590687
- Sponsor's protocol ID
- APHP240938
- Acronym
- KARMA
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
de Tymowski C, Depret F, Dudoignon E, Legrand M, Mallet V; Keta-Cov Research Group. Ketamine-induced cholangiopathy in ARDS patients. Intensive Care Med. 2021 Oct;47(10):1173-1174. doi: 10.1007/s00134-021-06482-3. Epub 2021 Jul 27. No abstract available.
PubMed 34313797Legrand M, Constantin JM, Burry L, Sonneville R. Ketamine and Traumatic Memory After Intensive Care Unit Discharge: Patient Population and Sedation Concerns. Anesth Analg. 2025 Oct 1;141(4):e48-e49. doi: 10.1213/ANE.0000000000007643. Epub 2025 Jul 17. No abstract available.
PubMed 40675617Amer M, Hylander Moller M, Alshahrani M, Shehabi Y, Arabi YM, Alshamsi F, Ingi Sigurethsson M, Rehn M, Chew MS, Kalliomaki ML, Lewis K, Al-Suwaidan FA, Al-Dorzi HM, Al-Fares A, Alsadoon N, Bell CM, Groth CM, Parke R, Mehta S, Wischmeyer PE, Al-Omari A, Olkkola KT, Alhazzani W. Ketamine Analgo-sedation for Mechanically Ventilated Critically Ill Adults: A Rapid Practice Guideline from the Saudi Critical Care Society and the Scandinavian Society of Anesthesiology and Intensive Care Medicine. Anesth Analg. 2025 Aug 1;141(2):309-326. doi: 10.1213/ANE.0000000000007173. Epub 2025 Jul 14.
PubMed 39207913Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.
PubMed 30113379
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Care Treatment With Adjuvant KetAmine and Recovery After Mechanical ventilAtion: a Multicenter Doubleblind Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07590687
- Acronym / sponsor ID
- KARMA / APHP240938
- Conditions
- Critical Illness
- Keywords
- Ketamine, Critical illness, Intensive care unit (ICU), Mechanical ventilation, Sedation, Delirium
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 640 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 19 Oct 2026 (estimated)
- Primary completion
- 19 Dec 2029 (estimated)
- Study completion
- 19 Jan 2030 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Invasive mechanical ventilation of critically ill patients in the intensive care unit (ICU) is associated with significant morbidity and mortality, as well as a severe prognosis in survivors, in terms of functional, psychological, and cognitive sequelae. During the initial phase, invasive mechanical ventilation aims to promote oxygenation and reduce respiratory effort, with most patients receiving continuous intravenous sedation comprising gamma-aminobutyric acid (GABA) agonists (propofol, midazolam), and opioids. This continuous intravenous sedation is associated with complications, particularly hemodynamic issues (e.g., hypotension, vasopressor dependency), and neurological concerns (e.g., coma, delayed awakening, withdrawal syndrome upon discontinuation of sedation) during the acute phase and is linked to prolonged mechanical ventilation and long-term neurocognitive sequelae.
The use of ketamine as an alternative sedative agent in ICU has garnered considerable attention in recent years. Ketamine has a rapid onset of action and a short duration of effect, potentially beneficial bronchodilatory effects, and minimal impact on hemodynamics or respiratory drive. It also provides effective analgesia. Due to its action on N-methyl-D-aspartate (NMDA) glutamatergic receptors, its mechanism of action differs from other commonly used agents such as propofol and benzodiazepines. Furthermore, emerging research suggests that ketamine may have anti-inflammatory/immunomodulatory and neuroprotective properties that could be advantageous in critically ill patients.
Recent observational studies utilizing low-dose ketamine have suggested an improvement in neurological complications in ICU (e.g., coma, delirium) while other authors have raised concerns about potential renal and hepatic toxicity associated with high doses of ketamine used for sedation. Despite its increasing use, there is currently a lack of high-quality data on the efficacy and safety of ketamine use for sedation in critically ill patients.
In this trial, we hypothesise that, critically ill patients requiring unplanned invasive mechanical ventilation, adjunctive treatment with low dose of ketamine will translate into better outcomes, with higher numbers of days alive outside of the hospital.
The study is a multicenter, randomised, double-blinded placebo-controlled superiority trial involving adult patients requiring unplanned mechanical ventilation, and sedation for more than 6 hours in the ICU. Patients will be randomised within 48 hours following initiation of mechanical ventilation adhering to a 1:1 allocation of ketamine or placebo.
Patients will be randomized to receive either intravenous ketamine or placebo as an adjunctive sedative agent during ICU stay for a maximum duration of 14 days.
Follow-up visits will be performed at day 3, day 14, ICU discharge, day 60, and day 90 after randomization.
The primary endpoint, "days alive and at home," will be assessed at day 60. The end of the research visit is the day 90 follow-up visit. If the patient has been discharged from the hospital, the day-90 visit will consist of telephone contact with the patient by a centralized research assistant and he also will complete the scales at D90.
Data collected by phone consist in Vital status, scales's results and Retrieval of Adverse Events if the patient has been discharged home or with the medical team of the healthcare structure if the patient has been discharged to another structure.
Detailed description
Phase III study Prospective, multicenter, superiority, double-blind, randomized controlled study with two arms (1:1).
The study includes a screening/baseline visit (V0), followed by daily assessments during the intervention period (V1 to V4), and post-discharge (V5) follow-up visits at Day 60 (V6) and Day 90 (V7).
At screening and baseline (within 48 hours prior to Day 1), eligibility is confirmed, and informed consent is obtained when possible. In cases where prior consent cannot be obtained, deferred consent procedures are applied in accordance with French legislation. Baseline data include medical history, comorbidities, concomitant treatments, clinical examination, and pregnancy testing when applicable.
Randomization is performed at Day 1 (V1). From Day 1 to Day 14 (V4), patients will be receive either intravenous ketamine or placebo as an adjunctive sedative agent during ICU stay for a maximum duration of 14 days.
Until ICU discharge (V5), patients undergo daily assessments including clinical examination, vital status, organ dysfunction (Sequential Organ Failure Assessment [SOFA] score), At Day 14 (V4), opioid and sedative consumption during the treatment period will be quantified.
At Day 60 (V6), ventilator-free days and vasopressor-free days will be assessed.
Duration of delirium and coma are assessed using the RASS/CAM-ICU, at V 4, during the first 14 days following randomization.
Biological monitoring includes daily measurement of serum creatinine and liver function parameters (ASAT, ALAT, gamma-GT, and bilirubin) to evaluate potential renal and hepatic toxicity. Adverse events are collected throughout the ICU stay, and assessed at Day 60 (V6) At ICU discharge (V5), a clinical evaluation and morbidity/mortality assessment are performed if the patient is still hospitalized.
The primary endpoint-the number of days alive and at home-is assessed at Day 60. Secondary outcomes, including mortality (all-cause deaths), are assessed at both Day 60 (V6) and Day 90(V7).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Two study groups will be formed: one will receive intravenous ketamine, while the other will receive an intravenous placebo
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Drug: Intervention GroupKetamine will be started at a dose of 0.2 mg/kg/hour for 4 hours and then adjusted as necessary (+/-0.1 mg/kg/hour every 4 hours) from 0 to 0.6 mg/kg/hour to maintain a targeted RASS of -1 to 0, in addition to standard per local sedation and pain protocols. Duration of treatment: 14 days in maximum |
| Control group | Placebo comparator | Drug: PlaceboIntravenous placebo will be started at a dose of 0.2 mg/kg/hour for 4 hours and adjusted as necessary (+/-0.1 mg/kg/hour every 4 hours) from 0 to 0.6 mg/kg/hour to maintain a targeted RASS of -1 to 0, in addition to standard sedation per local protocol. Duration of treatment : 14 days in maximum |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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])
Key exclusion criteria (16 listed)
- Refusal to participate in the study
- 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)
- Psychosis
- Status asthmaticus
- Current liver failure with Model for End-Stage Liver Disease (MELD) > 30
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention GroupKetamine ® is supplied in 250 mg/5 ml vials containing sterile solution for dilution in sodium chlorure 0.9% for infusions. | Drug | Intervention group |
| PlaceboPlacebo : NaCl 0.9% (vials) | Drug | Control group |
Primary outcome
Number of days patients are alive and spent at home
Time frame: At 60 days after ketamine initiation
This endpoint will be collected by an independent research assistant, blinded to randomization groups, , and not involved in data monitoring onsite.
10 secondary outcomes
Number of days alive free of encephalopathy
Time frame: During 14 days after randomization
number of days spent alive without invasive mechanical ventilation
Time frame: At day 60
Number of days spent alive without infusion norepinephrine infusion during ICU stay
Time frame: At day 60
Mortality
Time frame: At Day 60 et Day 90
Renal toxicity,
Time frame: At Day 60
Liver toxicity
Time frame: At Day 60
Quantification of opioid and sedative consumption
Time frame: Within the 14 days after randomization
Mean daily pain (BPS)
Time frame: During the first 14 days after randomisation
Cumulative incidence of hallucination events
Time frame: During 14 days after randomization
Mean daily sedation score (RASS)
Time frame: During the first 14 days after randomisation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Background: PubMed 34313797de Tymowski C, Depret F, Dudoignon E, Legrand M, Mallet V; Keta-Cov Research Group. Ketamine-induced cholangiopathy in ARDS patients. Intensive Care Med. 2021 Oct;47(10):1173-1174. doi: 10.1007/s00134-021-06482-3. Epub 2021 Jul 27. No abstract available.
- Background: PubMed 40675617Legrand M, Constantin JM, Burry L, Sonneville R. Ketamine and Traumatic Memory After Intensive Care Unit Discharge: Patient Population and Sedation Concerns. Anesth Analg. 2025 Oct 1;141(4):e48-e49. doi: 10.1213/ANE.0000000000007643. Epub 2025 Jul 17. No abstract available.
- Background: PubMed 39207913Amer M, Hylander Moller M, Alshahrani M, Shehabi Y, Arabi YM, Alshamsi F, Ingi Sigurethsson M, Rehn M, Chew MS, Kalliomaki ML, Lewis K, Al-Suwaidan FA, Al-Dorzi HM, Al-Fares A, Alsadoon N, Bell CM, Groth CM, Parke R, Mehta S, Wischmeyer PE, Al-Omari A, Olkkola KT, Alhazzani W. Ketamine Analgo-sedation for Mechanically Ventilated Critically Ill Adults: A Rapid Practice Guideline from the Saudi Critical Care Society and the Scandinavian Society of Anesthesiology and Intensive Care Medicine. Anesth Analg. 2025 Aug 1;141(2):309-326. doi: 10.1213/ANE.0000000000007173. Epub 2025 Jul 14.
- Background: PubMed 30113379Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.
Related trials for Critical Illness
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthieu Prof LEGRAND, M.D., Ph.D. contact
Romain Prof SONNEVILLE, MD-PHD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intervention Group in people with Critical Illness, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Romain Prof SONNEVILLE, MD-PHD (1 40 25 61 39 ext. 0033, romain.sonneville@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days patients are alive and spent at home (time frame: At 60 days after ketamine initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07590687, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.