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

ARDS Clinical Trial

Official title:

Effect of Inhalation Sedation With Sevoflurane Compared With Propofol on the Sepsis-related Acute Respiratory Distress Syndrome (ARDS) Course.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04014218
• Other study ID #: SS2019
• Status: Recruiting
• Phase: Phase 4
• Start date: January 8, 2019
• Est. completion date: January 2020

Study information

• Verified date: July 2019
• Source: Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy
• Contact: Valery V Likhvantsev,
• Phone: +7 (903) 623-59-82
• Email: lik0704[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 2020
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• sepsis

• ARDS

• P/F Ratio 100-250

• start of mechanical ventilation

Exclusion Criteria:

• pregnancy

• concomitant oncological disease

• prior psychological impairment

Related Conditions & MeSH terms

• Acute Lung Injury
• ARDS
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Sepsis

Intervention

Drug:
• Inhalation Sedation
Inhalation Sedation by Administration of Sevoflurane
• Intravenous Sedation
Intravenous Sedation by Administration of Propofol

Locations

Country	Name	City	State
Russian Federation	Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy	Moscow

Sponsors (2)

Lead Sponsor	Collaborator
Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy	I.M. Sechenov First Moscow State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality	28 days and in-hospital mortality	28 days after ICU admission
Primary	ICU Length of stay (LOS)	Length of stay in ICU	45 days after ICU admission
Primary	Length of mechanical ventilation (LMV)	Length of mechanical ventilation	45 days after ICU admission
Secondary	P/F Ratio	minimal pO2/FiO2	45 days after ICU admission
Secondary	Delirium	onset and duration of delirium	5 days after ICU admission
Secondary	MACCE	Major Adverse Cardiac and Cerebrovascular Event	28 days after ICU admission
Secondary	event of RRT	event of Renal Replacement Therapy	28 days after ICU admission