KARMA - INtenSive care TreAtmeNT with adjuvant KetAmine and Recovery after Mechanical ventilAtion: a multicenter doubleblind randomized controlled trial

简要总结

主要结局

次要结局

• The number of days alive free of encephalopathy (coma or delirium measured on the CAM-ICU) during 14 days after randomization
• The number of days spent alive without invasive mechanical ventilation (ventilation-free days) at 60 days;
• The number of days spent alive without infusion norepinephrine or inotropes infusion during ICU stay (vasopressors-free days) at 60 days;
• Mortality, defined by the prevalence of all-cause deaths at 60 and 90 days;
• Toxicité rénale, définie par la proportion de patients atteignant un stade KDIGO ≥2 à 60 jours ;
• Liver toxicity, defined by the highest bilirubin and phosphatase alkaline level during the first 60 days;
• Quantification of opioid and sedative consumption during the treatment period, in each arm during the first 14 days.
• Mean daily pain (BPS) and sedation (RASS) scores, in each arm during the first 14 days
• Cumulative incidence of hallucination events during 14 days after randomization
• Presence of anxiety and depression, defined by a score ≥11 on the anxiety and depression components of the Hospital Anxiety and Depression scale, respectively at 90 days; (tertiary outcome)
• Acute posttraumatic stressdisorder (PTSD)-related (measured on the ICU memory tool) at 90 days. (tertiary outcome)