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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04014218
Enrollment
80
Registered
2019-07-10
Start date
2019-01-08
Completion date
2020-01-31
Last updated
2019-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS

Keywords

sedation, ARDS, sepsis, outcome

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.

Interventions

DRUGInhalation Sedation

Inhalation Sedation by Administration of Sevoflurane

DRUGIntravenous Sedation

Intravenous Sedation by Administration of Propofol

Sponsors

I.M. Sechenov First Moscow State Medical University
CollaboratorOTHER
Moscow Regional Research and Clinical Institute (MONIKI)
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Masking description

opaque envelopes

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* pregnancy * concomitant oncological disease * prior psychological impairment

Design outcomes

Primary

MeasureTime frameDescription
mortality28 days after ICU admission28 days and in-hospital mortality
ICU Length of stay (LOS)45 days after ICU admissionLength of stay in ICU
Length of mechanical ventilation (LMV)45 days after ICU admissionLength of mechanical ventilation

Secondary

MeasureTime frameDescription
P/F Ratio45 days after ICU admissionminimal pO2/FiO2
event of RRT28 days after ICU admissionevent of Renal Replacement Therapy
Delirium5 days after ICU admissiononset and duration of delirium
MACCE28 days after ICU admissionMajor Adverse Cardiac and Cerebrovascular Event

Countries

Russia

Contacts

Primary ContactValery V Likhvantsev,
lik0704@gmail.com+7 (903) 623-59-82

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026