Effect of Sevoflurane, Propofol and Dexmedetomidine on De... | NCT02394418

Studies
Effect of Sevoflurane, Propofol and Dexmedetomidine on Delirium & Neuroinflammation in Mechanically Ventilated Patients

NCT02394418

Sponsor

Moscow Regional Research and Clinical Institute (MONIKI)

Status

Withdrawn

Last Update Posted

Aug 15, 2019Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Delirium

Interventions

Sevoflurane
Propofol
Dexmedetomidine

Countries

Not provided

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

Aug 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

for technical reasons

Expanded Access Info

Start Date

Sep 1, 2017Estimated

Primary Completion Date

May 2018Estimated

Completion Date

Aug 2018Estimated

First Submitted Date

Jan 27, 2015

First Submission Date that Met QC Criteria

Mar 16, 2015

First Posted Date

Mar 20, 2015Estimated

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

Aug 13, 2019

Last Update Posted Date

Aug 15, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Valery V. Likhvantsev, Professor, senior researcher, Moscow Regional Research and Clinical Institute (MONIKI)Principal Investigator

Lead Sponsor

Moscow Regional Research and Clinical Institute (MONIKI)OTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Assessment of sedative effects of sevoflurane, dexmedetomidine and propofol on the clinical course of delirium, SIRS and neuroinflammation in mechanically ventilated patients using CAM-ICU scale, GSK-3beta and protein S100b in serum.

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sevoflurane	Active Comparator	Treatment of delirium by inhaled sevoflurane	Drug: Sevoflurane
Propofol	Active Comparator	Treatment of delirium by propofol i.v. infusion	Drug: Propofol
Dexmedetomidine	Active Comparator	Treatment of delirium by dexmedetomidine i.v. infusion	Drug: Dexmedetomidine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sevoflurane	Drug	Treatment of delirium by inhaled sevoflurane	Sevoflurane

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Duration of Delirium	Delirium assessment by CAM-ICU scale	up to 5 days

Secondary Outcomes

Measure	Description	Time Frame
Change of protein S100b in serum		from delirium onset up to 5 days
Change of GSK-3beta in serum		from delirium onset up to 5 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

presence of delirium

Exclusion Criteria:

presence of Alzheimer's disease
any mental disorder
presence of cancer

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Valery Likhvantsev, MD,PhD	Moscow Regional Research Clinical Institute	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003693	Delirium

Ancestor Terms

ID	Term
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077149	Sevoflurane
D015742	Propofol
D020927	Dexmedetomidine

Ancestor Terms

ID	Term
D008738	Methyl Ethers
D004987	Ethers
D009930	Organic Chemicals
D006845	Hydrocarbons, Fluorinated

Browse Leaves

Not provided

Browse Branches

Not provided