NCT02394418

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2017

Shorter than P25 for phase_4

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 20, 2015

Completed
2.5 years until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

August 15, 2019

Status Verified

August 1, 2019

Enrollment Period

8 months

First QC Date

January 27, 2015

Last Update Submit

August 13, 2019

Conditions

Delirium

Outcome Measures

Primary Outcomes (1)

  • Duration of Delirium

    Delirium assessment by CAM-ICU scale

    up to 5 days

Secondary Outcomes (2)

  • 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

Study Arms (3)

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

SevofluraneDRUG

Treatment of delirium by inhaled sevoflurane

Also known as: Sevorane
Sevoflurane
PropofolDRUG

Treatment of delirium by propofol i.v. infusion

Also known as: Diprivan
Propofol
DexmedetomidineDRUG

Treatment of delirium by dexmedetomidine i.v. infusion

Also known as: Dexdor
Dexmedetomidine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • presence of delirium

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Delirium

Interventions

SevofluranePropofolDexmedetomidine

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Valery Likhvantsev, MD,PhD

    Moscow Regional Research Clinical Institute

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
senior researcher

Study Record Dates

First Submitted

January 27, 2015

First Posted

March 20, 2015

Study Start

September 1, 2017

Primary Completion

May 1, 2018

Study Completion

August 1, 2018

Last Updated

August 15, 2019

Record last verified: 2019-08