Isoflurane for Cardiogenic shock

Inclusion criteria

• {"criterion_text":"- Cardiogenic shock on VA ECMO support for less than 24 hours\n- Patients on invasive mechanical ventilation receiving propofol and/or midazolam at the time of randomization\n- Invasive mechanical ventilation for less than 48 hours\n- Expected invasive ventilation and sedation for at least 24h, with a prescribed Richmond agitation scale target within the range of -1 to - 4\n- Social security registration (AME excluded)"}

Exclusion criteria

• {"criterion_text":"- Age <18 and >75\n- Suspected or proven intracranial hypertension\n- Corrected QT interval > 450ms or with a known or suspected genetic predisposition to malignant hyperthermia\n- Chronic liver disease defined as a Child-Pugh score of 12-15\n- Patients ventilated with a tidal volume < 4ml/kg predicted body weight\n- Participation in another interventional study or being in the exclusion period at the end of a previous study.\n- Contraindication or allergies to isoflurane, propofol, midazolam or other halogenated anaesthetics\n- Pregnancy or breastfeeding\n- Initiation of ECMO >24 hours\n- Initiation of mechanical ventilation >48 hours\n- Cardiopulmonary Resuscitation >20 minutes before randomization\n- Patient moribund on the day of randomization, SAPS II >90"}

Primary endpoints

• {"endpoint_text":"- A composite outcome of mortality and number of days alive without invasive mechanical ventilation within 28 days following ECMO initiation (detail in protocol)","definition_or_measurement_approach":"Composite of mortality and number of ventilator-free days within 28 days following ECMO initiation; further details referenced in the protocol."}

Secondary endpoints

• {"endpoint_text":"- Overall survival within 28 days\n- Ventricular assist device or/and heart transplant on day 28\n- Number of ECMO-free days on day 14 and day 28\n- Number of inotropes-free days on day 14 and day 28\n- Number of ICU-free days on day 28\n- Number of ventilation-free days on day 14 and day 28\n- Delirium-free days (evaluated with Confusion Assessment Method for the ICU [CAM-ICU]) on day 14 and day 28\n- Daily morphine equivalent dose during mechanical ventilation until day 14\n- Daily propofol, and midazolam doses during mechanical ventilation until day 14\n- Daily propofol or midazolam bolus needed to achieve the prescribed sedation range until day 14\n- Daily neuroleptics need until day 14\n- Daily clonidine needs until day 14\n- Daily dexmedetomidine need until day 14\n- Rate of side effects possibly linked to ineffective sedation (self-extubation, accidental ECMO decannulation, catheter withdrawal, etc.)\n- Incidence of drugs side effects (refractory hypertension, malignant hyperthermia)\n- Primary and secondary endpoints in predefined subgroups: patients with pre-ECMO cardiac arrest, and patients with acute myocardial infarction.","definition_or_measurement_approach":"Endpoints include timepoint-specific measures (day 14 and day 28) and standard assessments: overall survival at 28 days; device/transplant status at day 28; ECMO-, inotrope-, ICU-, ventilation-free days counted at specified days; delirium evaluated with CAM-ICU; drug consumption measured as daily morphine-equivalent and daily doses of propofol/midazolam and use of boluses; adverse events rates including refractory hypertension and malignant hyperthermia; subgroup analyses for pre-ECMO cardiac arrest and acute myocardial infarction. Detailed definitions referenced in protocol."}

France

Earliest CTIS Part Ii Submission Date

16-04-2025

Latest Decision Or Authorization Date

23-05-2025

Processing Time Days

37

Number Of Sites

3

Number Of Participants

300

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"Organisation name Direction Générale de l’Offre des Soins du Ministère de la santé et de la prévent","duties_or_roles":"Monetary support / funder","organisation_type":""}
• {"country":"","full_name":"SEDANA MEDICAL AB","duties_or_roles":"Device manufacturer/supplier (Sedaconda ACD-S device and starter kits)","organisation_type":""}