Acute Respiratory Distress Syndrome Clinical Trial
Official title:
Effect of Early 48-hour Sevoflurane Inhalation on Gas Exchange and Inflammation in Patients Presenting With Acute Respiratory Distress Syndrome (ARDS) : a Monocentric, Prospective, Randomized Study.
Numerous trials support the efficacy and safety of volatile anesthetic agents, namely
inhalation of sevoflurane through dedicated devices, for the sedation of ICU patients.
Several preclinical studies have shown that sevoflurane inhalation improves gas exchange and
decreases pulmonary and systemic inflammation in experimental models of acute respiratory
distress syndrome (ARDS).
The purpose of our prospective monocentric, randomized, controlled trial is to evaluate the
effects of an early 48-hour sevoflurane inhalation on gas exchange and inflammation in
patients with ARDS.
BACKGROUND:
Acute respiratory distress syndrome (ARDS) is characterized by hypoxemic respiratory failure
that can be lethal in 30 to 60% of patients. Its pathophysiological landmark, diffuse
alveolar damage, is associated with alveolar inflammation, epithelial injury and alveolar
fluid clairance impairment.
Several preclinical studies have shown that early sevoflurane inhalation improves gas
exchange, reduces alveolar edema and attenuates pulmonary and systemic inflammation in
experimental models of ARDS.
To date, no clinical trial has assessed the effects of early sevoflurane inhalation in ARDS
patients.
DESIGN NARRATIVE:
The purpose of this prospective, randomized, controlled study is to evaluate the effects of
a 48-hour sevoflurane inhalation strategy on gas exchange and both systemic and pulmonary
inflammation in the early phase of ARDS.
After inclusion, ICU patients with moderate to severe ARDS (according to the Berlin
definition of ARDS criteria; JAMA 2010) will be randomized into two groups :
- a "conventional group", in which intravenous sedation with midazolam will be
administered
- a "sevoflurane group", in which patients will inhale sevoflurane during a 48
hour-period, through dedicated devices Arterial blood gases will be analyze before
randomization and at 24, 48, 72, 96, and 120 hours.
Bronchoalveolar lavages (BAL) and blood samples will be assessed before randomization and at
48 hours, in order to measure tumor necrosis factor-alpha (TNFα), interleukin (IL)-1β, IL-6,
IL-8 and sRAGE levels. Duplicate assays will be performed with Multiplex (TNFα/interleukins)
or ELISA (sRAGE).
During the 48-hour treatment period, bispectral index (BIS®) values ranging from 40 to 50
will be targeted and neuromuscular blocking agents (cisatracurium) will be administered in
both groups. Protective ventilation strategies will be applied, as well as other guidelines
or recommendations on the management of ICU patients with ARDS.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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