Effect of Inhalation Sedation Compared With Propofol on t... | NCT04014218

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

NCT04014218

Sponsor

Moscow Regional Research and Clinical Institute (MONIKI)

Status

Unknown status

Last Update Posted

Jul 10, 2019Actual

Enrollment

80Estimated

Phase

Phase 4

Conditions

ARDS

Interventions

Inhalation Sedation
Intravenous Sedation

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 8, 2019Actual

Primary Completion Date

Sep 2019Estimated

Completion Date

Jan 2020Estimated

First Submitted Date

Jul 2, 2019

First Submission Date that Met QC Criteria

Jul 9, 2019

First Posted Date

Jul 10, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2019

Last Update Posted Date

Jul 10, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Valery V. Likhvantsev, Professor, Professor, Head of Intensive Care Department Moscow Regional Clinical and Research Institute, Moscow Regional Research and Clinical Institute (MONIKI)Principal Investigator

Lead Sponsor

Moscow Regional Research and Clinical Institute (MONIKI)OTHER_GOV

Collaborators

Name	Class
I.M. Sechenov First Moscow State Medical University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Inhalation sedation	Experimental		Drug: Inhalation Sedation
Propofol	Active Comparator		Drug: Intravenous Sedation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Inhalation Sedation	Drug	Inhalation Sedation by Administration of Sevoflurane	Inhalation sedation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
P/F Ratio	minimal pO2/FiO2	45 days after ICU admission
Delirium	onset and duration of delirium	5 days after ICU admission

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

pregnancy
concomitant oncological disease
prior psychological impairment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Valery V Likhvantsev,	Contact	+7 (903) 623-59-82		lik0704@gmail.com

Overall Officials

Name	Affiliation	Role
Valery V Likhvantsev,	Moscow Regional Clinical and Research Institute, Department of Intensive Care	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy	Recruiting	Moscow		129110	Russia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis

Ancestor Terms

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided