BridgeMD
Inhaled isoflurane for SEdation of invasively ventilated PaTIents with cardiogenic shock on extracOrporeal membrane oxygeNation (INSEPTION)
EU CTIS ID: 2023-510261-94-00
What this study is testing
To assess in cardiogenic shock patients on VA-ECMO the efficacy of inhaled isoflurane via the anesthetic conserving device, on a composite outcome of mortality and the number of ventilator-free days at day 28 following ECMO onset.
- Therapeutic confirmatory (Phase III)
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
- Cardiogenic shock on VA ECMO support for less than 24 hours
- Patients on invasive mechanical ventilation receiving propofol and/or midazolam at the time of randomization
- Invasive mechanical ventilation for less than 48 hours
- Expected invasive ventilation and sedation for at least 24h, with a prescribed Richmond agitation scale target within the range of -1 to - 4
- Social security registration (AME excluded)
You likely can't join if
- Age <18 and >75
- Suspected or proven intracranial hypertension
- Corrected QT interval > 450ms or with a known or suspected genetic predisposition to malignant hyperthermia
- Chronic liver disease defined as a Child-Pugh score of 12-15
- Patients ventilated with a tidal volume < 4ml/kg predicted body weight
- Participation in another interventional study or being in the exclusion period at the end of a previous study.
See the full eligibility criteria
- Cardiogenic shock on VA ECMO support for less than 24 hours
- Patients on invasive mechanical ventilation receiving propofol and/or midazolam at the time of randomization
- Invasive mechanical ventilation for less than 48 hours
- Expected invasive ventilation and sedation for at least 24h, with a prescribed Richmond agitation scale target within the range of -1 to - 4
- Social security registration (AME excluded)
- Age <18 and >75
- Suspected or proven intracranial hypertension
- Corrected QT interval > 450ms or with a known or suspected genetic predisposition to malignant hyperthermia
- Chronic liver disease defined as a Child-Pugh score of 12-15
- Patients ventilated with a tidal volume < 4ml/kg predicted body weight
- Participation in another interventional study or being in the exclusion period at the end of a previous study.
- Contraindication or allergies to isoflurane, propofol, midazolam or other halogenated anaesthetics
- Pregnancy or breastfeeding
- Initiation of ECMO >24 hours
- Initiation of mechanical ventilation >48 hours
- Cardiopulmonary Resuscitation >20 minutes before randomization
- Patient moribund on the day of randomization, SAPS II >90
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.