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

Primary Purpose

ARDS

Status

Unknown status

Phase

Phase 4

Locations

Russian Federation

Study Type

Interventional

Intervention

Inhalation Sedation

Intravenous Sedation

About this trial

This is an interventional treatment trial for ARDS focused on measuring sedation, ARDS, sepsis, outcome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

pregnancy
concomitant oncological disease
prior psychological impairment

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Inhalation sedation

Propofol

Arm Description

Outcomes

Primary Outcome Measures

mortality

28 days and in-hospital mortality

ICU Length of stay (LOS)

Length of stay in ICU

Length of mechanical ventilation (LMV)

Length of mechanical ventilation

Secondary Outcome Measures

P/F Ratio

minimal pO2/FiO2

Delirium

onset and duration of delirium

MACCE

Major Adverse Cardiac and Cerebrovascular Event

event of RRT

event of Renal Replacement Therapy

Full Information

NCT ID

NCT04014218

First Posted

July 2, 2019

Last Updated

July 9, 2019

Sponsor

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

Collaborators

I.M. Sechenov First Moscow State Medical University

1. Study Identification

Unique Protocol Identification Number

NCT04014218

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Unknown status

Study Start Date

January 8, 2019 (Actual)

Primary Completion Date

September 2019 (Anticipated)

Study Completion Date

January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

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

Collaborators

I.M. Sechenov First Moscow State Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

ARDS

Keywords

sedation, ARDS, sepsis, outcome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Investigator

Masking Description

opaque envelopes

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Inhalation sedation

Arm Type

Experimental

Arm Title

Propofol

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Inhalation Sedation

Intervention Description

Inhalation Sedation by Administration of Sevoflurane

Intervention Type

Drug

Intervention Name(s)

Intravenous Sedation

Intervention Description

Intravenous Sedation by Administration of Propofol

Primary Outcome Measure Information:

Title

mortality

Description

28 days and in-hospital mortality

Time Frame

28 days after ICU admission

Title

ICU Length of stay (LOS)

Description

Length of stay in ICU

Time Frame

45 days after ICU admission

Title

Length of mechanical ventilation (LMV)

Description

Length of mechanical ventilation

Time Frame

45 days after ICU admission

Secondary Outcome Measure Information:

Title

P/F Ratio

Description

minimal pO2/FiO2

Time Frame

45 days after ICU admission

Title

Delirium

Description

onset and duration of delirium

Time Frame

5 days after ICU admission

Title

MACCE

Description

Major Adverse Cardiac and Cerebrovascular Event

Time Frame

28 days after ICU admission

Title

event of RRT

Description

event of Renal Replacement Therapy

Time Frame

28 days after ICU admission

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: sepsis ARDS P/F Ratio 100-250 start of mechanical ventilation Exclusion Criteria: pregnancy concomitant oncological disease prior psychological impairment

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Valery V Likhvantsev,

Phone

+7 (903) 623-59-82

lik0704@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Valery V Likhvantsev,

Organizational Affiliation

Moscow Regional Clinical and Research Institute, Department of Intensive Care

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Moscow

ZIP/Postal Code

129110

Country

Russian Federation

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Valery V Likhvantsev, Professor

Phone

+7 (903) 623-59-82

lik0704@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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