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

NCT ID: NCT04014218

Last Updated: 2019-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-08

Study Completion Date

2020-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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ARDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
opaque envelopes

Study Groups

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Inhalation sedation

Group Type EXPERIMENTAL

Inhalation Sedation

Intervention Type DRUG

Inhalation Sedation by Administration of Sevoflurane

Propofol

Group Type ACTIVE_COMPARATOR

Intravenous Sedation

Intervention Type DRUG

Intravenous Sedation by Administration of Propofol

Interventions

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Inhalation Sedation

Inhalation Sedation by Administration of Sevoflurane

Intervention Type DRUG

Intravenous Sedation

Intravenous Sedation by Administration of Propofol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* pregnancy
* concomitant oncological disease
* prior psychological impairment
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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I.M. Sechenov First Moscow State Medical University

OTHER

Sponsor Role collaborator

Moscow Regional Research and Clinical Institute (MONIKI)

OTHER_GOV

Sponsor Role lead

Responsible Party

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Valery V. Likhvantsev, Professor

Professor, Head of Intensive Care Department Moscow Regional Clinical and Research Institute

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Valery V Likhvantsev,

Role: PRINCIPAL_INVESTIGATOR

Moscow Regional Clinical and Research Institute, Department of Intensive Care

Locations

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

Moscow, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Valery V Likhvantsev,

Role: CONTACT

+7 (903) 623-59-82

Facility Contacts

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Valery V Likhvantsev, Professor

Role: primary

+7 (903) 623-59-82

Other Identifiers

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SS2019

Identifier Type: -

Identifier Source: org_study_id

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