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Trial · NCT07099014

Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryA composite hierarchical outcome composed of two components: 1) mortality, 2) number of days alive without invasive mechanical ventilation within 28 days following ECMO initiationDay 28
* Each patient will be compared with every other patient in the study and assigned a score (tie: 0, win: +1, loss: -1) for each pairwise comparison based on whom fared better. * If one patient survived on day 28 and the other did not, scores of +1 and -1 will be assigned, respectively, for that pairwise comparison. If both patients in the pairwise comparison survived at day 28, the assigned score will depend on which patient had more days free from mechanical ventilation: the patient with more ventilator-free days alive at day 28 will receive a score of +1, while the patient with fewer days will receive a score of -1. If both patients survived and had the same number of ventilator-free days on day 28, and if both patients died, they will be both assigned a score of 0 for that pairwise comparison. For each patient, scores for all pairwise comparisons will be summed, resulting in a cumulative score.
SecondaryOverall survivalDay 28
SecondaryNumber of ECMO-free daysDay 14, Day 28
SecondaryNumber of inotropes-free daysDay 14, Day 28
SecondaryNumber of ICU-free daysDay 28
SecondaryNumber of ventilation-free daysDay 14, Day 28
Secondaryincidence of deliriumDay 28
SecondaryOpioids daily consumption during invasive mechanical ventilationDay 14
SecondaryConsumption of propofolDay 14consumption during invasive mechanical ventilation
SecondaryConsumption of midazolamDay 14consumption during invasive mechanical ventilation
SecondaryConsumption of ClonidineDay 14consumption during invasive mechanical ventilation
SecondaryConsumption of HaloperidolDay 14consumption during invasive mechanical ventilation
SecondaryConsumption of dexmedetomidineDay 14consumption during invasive mechanical ventilation
SecondaryIncidence of drugs side effects (refractory hypertension, malignant hyperthermia)From randomization to Day 28assess the safety of prolonged isoflurane inhalation during ECMO
SecondaryNumber of participants requiring ventricular assist deviceDay 28
SecondaryNumber of participants undergoing heart transplantationDay 28
SecondaryRate of side effects possibly linked to ineffective sedation (self-extubation, accidental ECMO decannulation, catheter withdrawal)From randomization to Day 28

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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