NCT04014218

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2019

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 10, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

July 10, 2019

Status Verified

July 1, 2019

Enrollment Period

8 months

First QC Date

July 2, 2019

Last Update Submit

July 9, 2019

Conditions

ARDS

Keywords

sedationARDSsepsisoutcome

Outcome Measures

Primary Outcomes (3)

  • mortality

    28 days and in-hospital mortality

    28 days after ICU admission

  • ICU Length of stay (LOS)

    Length of stay in ICU

    45 days after ICU admission

  • Length of mechanical ventilation (LMV)

    Length of mechanical ventilation

    45 days after ICU admission

Secondary Outcomes (4)

  • P/F Ratio

    45 days after ICU admission

  • Delirium

    5 days after ICU admission

  • MACCE

    28 days after ICU admission

  • event of RRT

    28 days after ICU admission

Study Arms (2)

Inhalation sedation

EXPERIMENTAL
Drug: Inhalation Sedation

Propofol

ACTIVE COMPARATOR
Drug: Intravenous Sedation

Interventions

Inhalation SedationDRUG

Inhalation Sedation by Administration of Sevoflurane

Inhalation sedation
Intravenous SedationDRUG

Intravenous Sedation by Administration of Propofol

Propofol

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • pregnancy
  • concomitant oncological disease
  • prior psychological impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy

Moscow, 129110, Russia

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Valery V Likhvantsev,

    Moscow Regional Clinical and Research Institute, Department of Intensive Care

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Valery V Likhvantsev,

CONTACT

+7 (903) 623-59-82lik0704@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
opaque envelopes
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Head of Intensive Care Department Moscow Regional Clinical and Research Institute

Study Record Dates

First Submitted

July 2, 2019

First Posted

July 10, 2019

Study Start

January 8, 2019

Primary Completion

September 1, 2019

Study Completion

January 1, 2020

Last Updated

July 10, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)