COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04530188

Xavier Monnet, MD, PhD

xavier.monnet@aphp.fr

2020-08-28

Unknown

RCT

Randomized

Parallel

Open label

unclear

Treatment

inclusion criteria: age ≥18 years presence of acute respiratory distress syndrome for ≤24 hours of all of the following conditions, within one week of a clinical insult or new or worsening respiratory symptoms: pao2/fio2 <150 mmhg with positive end-expiratory pressure (peep) ≥8 cmh2o (or, if arterial blood gas not available, spo2/fio2 that is equivalent to a pao2/fio2 <150 mmhg with peep ≥8 cmh2o and a confirmatory spo2/fio2 between 1-6 hours after the initial spo2/fio2 determination) bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules respiratory failure not fully explained by cardiac failure or fluid overload; need objective assessment (e.g., echocardiography) to exclude hydrostatic edema if no risk factor present pao2/fio2 <200 mmhg after meeting inclusion criteria and before randomization

absence of affiliation to the french sociale security patient under a tutelage measure or placed under judicial protection known pregnancy currently receiving ecmo therapy chronic liver disease defined as a child-pugh score of 12-15 severe hepatic failure expected duration of mechanical ventilation <48 hours moribund patient, i.e. not expected to survive 24 hours despite intensive care burns >70% total body surface previous hypersensitivity or anaphylactic reaction to sevoflurane medical history of malignant hyperthermia medical history of liver disease attributed to previous exposure to a halogenated agent known hypersensitivity to propofol or any of its components suspected or proven intracranial hypertension tidal volume of 6 ml/kg predicted body weight (pbw) below 200 ml (as recommended by the manufacturer for the use of the anaconda-s (sedana medical, danderyd, sweden) enrollment in another interventional ards trial with direct impact on sedation and mechanical ventilation

2

Bicetre Hospital

18

99

None

Severe disease at enrollment

6: Severe disease at enrollment

68

Time course of extravascular lung water (EVLW);Time course of pulmonary vascular permeability index (PVPI)

None

Phase 3

[{"arm_notes": "", "treatment_id": 1029, "treatment_name": "Propofol", "treatment_type": "Central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1186, "treatment_name": "Sevoflurane", "treatment_type": "Central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}]