Effect of Inhalation Sedation Compared With Propofol on the Sepsis-related Acute Respiratory Distress Syndrome Course

Phase 4

• Conditions: ARDS
• Interventions: Drug: Inhalation Sedation; Drug: Intravenous Sedation

• Registration Number: NCT04014218
• Lead Sponsor: Moscow Regional Research and Clinical Institute (MONIKI)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-08
• Status Verified: 2019-07
• Study First Submitted: 2019-07-02
• Study First Submitted QC: 2019-07-09
• Last Update Submitted: 2019-07-09
• Study First Posted: 2019-07-10
• Last Update Posted: 2019-07-10
• Primary Completion: 2019-09
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• sepsis
• ARDS
• P/F Ratio 100-250
• start of mechanical ventilation

Exclusion Criteria

• pregnancy
• concomitant oncological disease
• prior psychological impairment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inhalation sedation	Inhalation Sedation	-
Propofol	Intravenous Sedation	-

Primary Outcome Measures

Name	Time	Method
mortality	28 days after ICU admission	28 days and in-hospital mortality
ICU Length of stay (LOS)	45 days after ICU admission	Length of stay in ICU
Length of mechanical ventilation (LMV)	45 days after ICU admission	Length of mechanical ventilation

Secondary Outcome Measures

Name	Time	Method
event of RRT	28 days after ICU admission	event of Renal Replacement Therapy
MACCE	28 days after ICU admission	Major Adverse Cardiac and Cerebrovascular Event
P/F Ratio	45 days after ICU admission	minimal pO2/FiO2
Delirium	5 days after ICU admission	onset and duration of delirium

Trial Locations

Locations (1)

Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy; 🇷🇺 Moscow, Russian Federation