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Trial · NCT06851078

Registered outcomes16

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

ListOutcomeTime frameDescription
PrimaryNumber of days alive without delirium or coma14 days after randomization
SecondaryMortality in intensive careAt day 28
SecondaryMortality in intensive careAt day 90
SecondaryMortality in hospitalAt day 28
SecondaryMortality in hospitalAt day 90
SecondaryOverall survivalAt day 90
SecondaryDuration of mechanical ventilationAt day 28
SecondaryLength of stay in intensive care unitUp to day 90
SecondaryLength of stay in hospitalUp to day 90
SecondaryOccurrence of epileptic seizuresUp to day 14From Day 1 to Day 14 (confirmed by EEG or tonic-clonic seizures) and/or occurrence of epileptic abnormalities (periodic epileptic discharges)
SecondaryTime between cessation of sedation and awakeningAt day 90Defined by spontaneous eye opening, among patients not deceased under sedation
SecondarySeverity of cognitive impairmentAt day 90
Evaluated by a telephone survey using Telephone MoCA (Montreal Cognitive Assessment). The scores ranges from 0 to 30. A score of 26 or higher is typically considered normal. A score of 25 or lower may indicate cognitive impairment, such as mild cognitive impairment (MCI) or early-stage dementia.
SecondarySeverity of anxiety and depressionAt day 90Assessed with HADS (Hospital Anxiety and Depression Scale) scale Score varies from 0 to 21 for each componant (Anxiety and depression) The higher the score, the more severe the anxiety or depression.
SecondaryPresence of post-traumatic stress (PTSD)At day 90
Assessed by IES-R (Impact of Event Scale Revisited) The total score can range from 0 to 88. Higher scores indicate greater trauma-related distress and a higher likelihood of experiencing PTSD symptoms.
SecondaryQuality of life scoringAt day 90
Using EQ-5D-5L. It evaluates five dimensions : mobility, self-care, usual activities, pain/discomfort and anxiety/depression and each dimension has five levels : no problems, slight problems, moderate problems, severe problems and extreme problems. Answers are given on a 5-point scale by domain, the higher the score, the poorer the quality of life.
SecondaryAutonomy in daily lifeAt day 90Using Katz Index of Independence in Activities of Daily Living (ADL) The score varies from 0 to 6, the lower the score, the more dependent the person.

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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