NCT04014218
Unknown
Phase 4
Effect of Inhalation Sedation With Sevoflurane Compared With Propofol on the Sepsis-related Acute Respiratory Distress Syndrome (ARDS) Course.
Moscow Regional Research and Clinical Institute (MONIKI)1 site in 1 country80 target enrollmentJanuary 8, 2019
ConditionsARDS
Overview
- Phase
- Phase 4
- Intervention
- Inhalation Sedation
- Conditions
- ARDS
- Sponsor
- Moscow Regional Research and Clinical Institute (MONIKI)
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- mortality
- Last Updated
- 6 years ago
Overview
Brief Summary
Investigation of effect of inhalation sedation by administration of Sevoflurane compared with Propofol on the moderate acute respiratory distress syndrome course in mechanically ventilated patients with sepsis.
Investigators
Valery V. Likhvantsev, Professor
Professor, Head of Intensive Care Department Moscow Regional Clinical and Research Institute
Moscow Regional Research and Clinical Institute (MONIKI)
Eligibility Criteria
Inclusion Criteria
- •P/F Ratio 100-250
- •start of mechanical ventilation
Exclusion Criteria
- •pregnancy
- •concomitant oncological disease
- •prior psychological impairment
Arms & Interventions
Inhalation sedation
Intervention: Inhalation Sedation
Propofol
Intervention: Intravenous Sedation
Outcomes
Primary Outcomes
mortality
Time Frame: 28 days after ICU admission
28 days and in-hospital mortality
ICU Length of stay (LOS)
Time Frame: 45 days after ICU admission
Length of stay in ICU
Length of mechanical ventilation (LMV)
Time Frame: 45 days after ICU admission
Length of mechanical ventilation
Secondary Outcomes
- event of RRT(28 days after ICU admission)
- MACCE(28 days after ICU admission)
- P/F Ratio(45 days after ICU admission)
- Delirium(5 days after ICU admission)
Study Sites (1)
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