Status:
TERMINATED
Sevoflurane PharmacokInetics in ARDS
Lead Sponsor:
University Hospital, Clermont-Ferrand
Conditions:
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The main objective of this study is to compare the pharmacokinetic models of sevoflurane-induced sedation during ARDS depending on the lung imaging phenotype (focal vs nonfocal phenotypes) The authors...
Detailed Description
Adult patients admitted to the ICU within 12 hours of moderate-severe ARDS onset and under sedation with sevoflurane will be enrolled in the study with inclusion criteria. They will be enrolled, depen...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Presence for ≤ 12 hours of all of the following conditions, within one week of a clinical insult or new or worsening respiratory symptoms :
- a PaO2/FiO2 \< 200 mmHg with positive end-expiratory pressure (PEEP) ≥ 8 cmH2O (or, if arterial blood gas not available : SpO2/FiO2 ratio that is equivalent to a PaO2/FiO2 \< 200 mmHg with PEEP ≥8 cmH2O, and a confirmatory SpO2/FiO2 ratio between 1-6 hours after the initial SpO2/FiO2 ratio determination) b Bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules c 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
Exclusion
- Lack of informed consent
- Continuous sedation with inhaled sevoflurane at enrollment
- Currently receiving ECMO therapy
- Chronic respiratory failure defined as PaCO2 \> 60 mmHg in the outpatient setting
- Home mechanical ventilation (non-invasive ventilation or via tracheotomy) except for CPAP/BIPAP used solely for sleep-disordered breathing
- Body mass index \> 40 kg/m2
- Chronic liver disease defined as a Child-Pugh score of 12-15
- Expected duration of mechanical ventilation \< 48 hours
- Tidal volume of 6 mL/kg predicted body weight (PBW) below 200 mL
- Decision to withhold life-sustaining treatment; except in those patients committed to full support except cardiopulmonary resuscitation
- 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
- Suspected or proven intracranial hypertension
- Know pregnancy - Pregnancy testing will be systematically performed to rule out pregnancy in female patients of reproductive age
- Enrollment in another interventional ARDS trial with direct impact on sedation and PEEP
- Endotracheal ventilation for greater than 120 hours (5 days)
- PaO2/FiO2 (if available) \> 200 mmHg after meeting inclusion criteria and before start of the study
Key Trial Info
Start Date :
February 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2022
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT04023305
Start Date
February 23 2020
End Date
January 1 2022
Last Update
December 19 2023
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre Jean Perrin
Clermont-Ferrand, France
2
CHU
Clermont-Ferrand, France
3
APHP - University hospital of Saint-Louis
Paris, France, 75010