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

July 9, 2019 updated by: Valery V. Likhvantsev, Professor, Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 129110
        • Recruiting
        • Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy
        • Contact:
          • Valery V Likhvantsev, Professor
          • Phone Number: +7 (903) 623-59-82
          • Email: lik0704@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnancy
  • concomitant oncological disease
  • prior psychological impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Propofol
Drug: Intravenous Sedation
Intravenous Sedation by Administration of Propofol
Experimental: Inhalation sedation
Drug: Inhalation Sedation
Inhalation Sedation by Administration of Sevoflurane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality
Time Frame: 28 days after ICU admission
28 days and in-hospital mortality
28 days after ICU admission
ICU Length of stay (LOS)
Time Frame: 45 days after ICU admission
Length of stay in ICU
45 days after ICU admission
Length of mechanical ventilation (LMV)
Time Frame: 45 days after ICU admission
Length of mechanical ventilation
45 days after ICU admission

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

I.M. Sechenov First Moscow State Medical University

Investigators

  • Principal Investigator: Valery V Likhvantsev,, Moscow Regional Clinical and Research Institute, Department of Intensive Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2019

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

July 2, 2019

First Submitted That Met QC Criteria

July 9, 2019

First Posted (Actual)

July 10, 2019

Study Record Updates

Last Update Posted (Actual)

July 10, 2019

Last Update Submitted That Met QC Criteria

July 9, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SS2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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