Patients in ICU with risks of Acute Respiratory Distress Syndrome
Conditions
Interventions
Trade Name: SEVOFLURANE
Product Name: SEVOFLURANE
Pharmaceutical Form: Inhalation vapour, liquid
INN or Proposed INN: SEVOFLURANE
CAS Number: 28523-86-6
Other descriptive name: SEVOFLURANE
Concentrati
Sponsors
CHU de CLERMONT-FERRAND
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years 2. Admitted to participating ICUs with at least one known risk factor for ARDS and a LIPS equals to, or greater than, 4 (Appendix G)105 3. Patient under invasive mechanical ventilation 4. With expected duration of sedation superior or equal to 4 hours 5. Affiliation to the French Sécurité Sociale Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: - Patient under a tutelage measure - Known pregnancy - Presence of ARDS prior to randomization - Endotracheal ventilation for greater than 24 hours prior to randomization - Home mechanical ventilation (non-invasive ventilation or via tracheotomy) except for CPAP/BIPAP used solely for sleep-disordered breathing - Tidal volume of 6 mL/kg predicted body weight (PBW) below 200 mL (i.e. height inferior to 134cm for a man and 139cm for a woman) - Moribund patient, i.e. not expected to survive 24 hours despite intensive care - Previous hypersensitivity or anaphylactic reaction to sevoflurane - Medical history of malignant hyperthermia - Long QT syndrome at risk of arrhythmic events - Medical history of liver disease attributed to previous exposure to a halogenated agent (including sevoflurane) - Suspected or proven intracranial hypertension - Enrollment in another interventional trial with direct impact on oxygenation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of inhaled sevoflurane, compared to current intravenous sedation practice, for improving PaO2/FiO2 in ICU patients at high risk for ARDS.;Secondary Objective: - Progression to ARDS, as defined by the Berlin criteria1 . - Safety (clinical adverse events) of the two sedation strategies. - Effects on the rate of pneumonia. - Effects on respiratory mechanics. - Effects on gas exchange and physiologic measures. - Effects on ICU-acquired delirium. - Effects on ICU-acquired weakness. - Effects on hemodynamic measures and renal function (KDIGO criteria for acute kidney injury24). - Effects on organ dysfunction. - Effects on the duration of mechanical ventilation. - Effects on 28-day mortality. - Effects on the number of days off the ventilator at 28 days (ventilator-free days to day 28, VFD28), taking into account death as a competing event. - Biological collection of plasma, alveolar edema fluid, and urine samples for future mechanistic and endotyping studies of the biological effects of sevoflurane. - Presence of subphenotypes among patients at risk of developing ARDS; - Hhealthcare-related costs during ICU stay and hospital stay. ;Primary end point(s): The primary outcome is longitudinal evolution in the PaO2/FiO2 ratio ;Timepoint(s) of evaluation of this end point: Day 5 after admission in ICU. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Progression to ARDS will be assessed according to the Berlin criteria, including chest radiographs. - Rate of pneumonia - Ventilator-free days - Organ failure-free days - Mortality - Length of ICU-stay - Physiological measures - ICU-acquired weakness - ICU-acquired delirium - Health economic analysis - Biomarker measurements;Timepoint(s) of evaluation of this end point: Day 28 | — |
Countries
France
Contacts
Public ContactInvestigator Coordonator
CHU CLERMONT-FERRAND
Outcome results
None listed