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Effects of SEvoflurane on Gas Exchange and Inflammation in Patients With ARDS (SEGA Study) (SEGA)

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ClinicalTrials.gov Identifier: NCT02166853
Recruitment Status : Completed
First Posted : June 18, 2014
Last Update Posted : March 4, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Drug: sevoflurane Drug: midazolam Phase 4

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : April 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : March 2016


Arm Intervention/treatment
Experimental: conventional group
a "conventional group", in which intravenous sedation with midazolam will be administered
Drug: midazolam
Sedation with intravenous midazolam

Experimental: sevoflurane group
a "sevoflurane group", in which patients will inhale sevoflurane during a 48 hour-period, through dedicated devices
Drug: sevoflurane
Sedation with inhaled sevoflurane




Primary Outcome Measures :
  1. PaO2/FiO2 ratio [ Time Frame: at 48 hours ]

Secondary Outcome Measures :
  1. - Plasma and alveolar levels of proinflammatory cytokines : tumor necrosis factor alpha (TNFα, interleukin (IL)-1β, IL-6, IL-8 [ Time Frame: at 48 hours ]
  2. Plasma and alveolar levels of sRAGE [ Time Frame: at 48 hours ]
  3. PaO2/FiO2 ratio [ Time Frame: at day 1, day 3, day 5 ]
  4. Lowest PaO2/FiO2 during the first 5 days of the study [ Time Frame: at 5 days ]
  5. Mean PaO2/FiO2 ratio during the first 5 days of the study [ Time Frame: at 5 days ]
  6. Pulmonary static compliance, resistance and elastance [ Time Frame: at day 1, day 2 ]
  7. Duration of controlled mechanical ventilation [ Time Frame: at day 30 ]
  8. Total duration of mechanical ventilation (controlled/assisted) [ Time Frame: at day 30 ]
  9. Number of ventilatory-free days [ Time Frame: at day 30 ]
  10. Number of organ failure-free days [ Time Frame: at day 30 ]
  11. Vasopressor requirements [ Time Frame: at 48 hours ]
  12. Mortality [ Time Frame: at day 30 ]


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with criteria for moderate to severe ARDS since less than 24 hours (
  • Informed consent

Exclusion Criteria:

  • Suspected or proven intracranial hypertension
  • Midazolam, sevoflurane or cisatracurium allergy
  • Medical history of malignant hyperthermia
  • Severe liver failure
  • Chemotherapy treatment in the last month
  • Severe neutropenia (< 0.5 G/l)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02166853


Locations
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France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Matthieu JABAUDON University Hospital, Clermont-Ferrand

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02166853     History of Changes
Other Study ID Numbers: CHU-0195
2013-005389-21
First Posted: June 18, 2014    Key Record Dates
Last Update Posted: March 4, 2016
Last Verified: March 2016
Keywords provided by University Hospital, Clermont-Ferrand:
Acute respiratory distress syndrome (ARDS)
Sevoflurane
Mechanical ventilation
Intensive Care Unit (ICU)
Prospective study
Lung injury
Gas exchange
Inflammation
Receptor for advanced glycation end-produts (RAGE)
sRAGE
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Inflammation
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Midazolam
Sevoflurane
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors