NCT02366299

Brief Summary

Assessment of sedative effects of dexmedetomidine and propofol on the clinical course of delirium and neuroinflammation in patients with SIRS using CAM-ICU scale 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 Feb 2015

Longer than P75 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withdrawn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 26, 2015

Completed
6 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 19, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

August 14, 2019

Status Verified

August 1, 2019

Enrollment Period

3.8 years

First QC Date

January 26, 2015

Last Update Submit

August 13, 2019

Conditions

Delirium

Outcome Measures

Primary Outcomes (1)

  • CAM-ICU scale

    up to 5 days

Study Arms (2)

dexmedetomidine

ACTIVE COMPARATOR

Treatment of delirium by dexmedetomidine i.v. infusion

Drug: Dexmedetomidine

propofol

ACTIVE COMPARATOR

Treatment of delirium by propofol i.v. infusion

Drug: Propofol

Interventions

DexmedetomidineDRUG

Treatment of delirium by dexmedetomidine i.v. infusion

Also known as: Dexdor
dexmedetomidine
PropofolDRUG

Treatment of delirium by Propofol i.v. infusion

Also known as: Diprivan
propofol

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

DexmedetomidinePropofol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
senior researcher

Study Record Dates

First Submitted

January 26, 2015

First Posted

February 19, 2015

Study Start

February 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

August 14, 2019

Record last verified: 2019-08