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Inhaled isoflurane for SEdation of invasively ventilated PaTIents with cardiogenic shock on extracOrporeal membrane oxygeNation (INSEPTION)

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-510261-94-00
Acronym
APHP230844
Enrollment
300
Registered
2025-05-23
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult patients with severe cardiogenic shock on venoarterial ECMO support for less than 24 hours.

Brief summary

A composite outcome of mortality and number of days alive without invasive mechanical ventilation within 28 days following ECMO initiation (detail in protocol)

Detailed description

Overall survival within 28 days, Ventricular assist device or/and heart transplant on day 28, Number of ECMO-free days on day 14 and day 28, Number of inotropes-free days on day 14 and day 28, Number of ICU-free days on day 28, Number of ventilation-free days on day 14 and day 28, Delirium-free days (evaluated with Confusion Assessment Method for the ICU [CAM-ICU]) on day 14 and day 28, Daily morphine equivalent dose during mechanical ventilation until day 14, Daily propofol, and midazolam doses during mechanical ventilation until day 14, Daily propofol or midazolam bolus needed to achieve the prescribed sedation range until day 14, Daily neuroleptics need until day 14, Daily clonidine needs until day 14, Daily dexmedetomidine need until day 14, Rate of side effects possibly linked to ineffective sedation (self-extubation, accidental ECMO decannulation, catheter withdrawal, etc.), Incidence of drugs side effects (refractory hypertension, malignant hyperthermia), Primary and secondary endpoints in predefined subgroups: patients with pre-ECMO cardiac arrest, and patients with acute myocardial infarction.

Interventions

DRUGPROPOFOL
DRUGMIDAZOLAM
DRUGCEDACONDA 100 % V/V

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
A composite outcome of mortality and number of days alive without invasive mechanical ventilation within 28 days following ECMO initiation (detail in protocol)

Secondary

MeasureTime frame
Overall survival within 28 days, Ventricular assist device or/and heart transplant on day 28, Number of ECMO-free days on day 14 and day 28, Number of inotropes-free days on day 14 and day 28, Number of ICU-free days on day 28, Number of ventilation-free days on day 14 and day 28, Delirium-free days (evaluated with Confusion Assessment Method for the ICU [CAM-ICU]) on day 14 and day 28, Daily morphine equivalent dose during mechanical ventilation until day 14, Daily propofol, and midazolam doses during mechanical ventilation until day 14, Daily propofol or midazolam bolus needed to achieve the prescribed sedation range until day 14, Daily neuroleptics need until day 14, Daily clonidine needs until day 14, Daily dexmedetomidine need until day 14, Rate of side effects possibly linked to ineffective sedation (self-extubation, accidental ECMO decannulation, catheter withdrawal, etc.), Incidence of drugs side effects (refractory hypertension, malignant hyperthermia), Primary and secondary e

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026