NCT02200159

Brief Summary

Research predictive factors of success or failure of a sedation with Dexmedetomidine in ICU

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

June 1, 2014

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2014

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 25, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

November 26, 2014

Status Verified

November 1, 2014

Enrollment Period

1.5 years

First QC Date

June 30, 2014

Last Update Submit

November 25, 2014

Conditions

Requiring Sedation in ICUAdult PatientsPatient Covered by French Health Care System

Keywords

SedationDexmedetomidineICUDelirium

Outcome Measures

Primary Outcomes (1)

  • Number of patients with failure of sedation with dexmedetomidine

    Number of patients with failure of sedation with dexmedetomidine (necessity to stop this sedation due to adverse event, RASS\>+1, other) in ICU patients requiring such sedation during ICU stay.

    at day 1

Secondary Outcomes (2)

  • Incidence of adverse event of dexmedetomidine

    at day 1

  • Incidence of delirium and use of other sedative drugs

    at day 1

Study Arms (1)

dexmedetomidine

Drug: Sedation with dexmedetomidine

Interventions

Sedation with dexmedetomidineDRUG
dexmedetomidine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients ventilated requiring sedation in ICU with RASS objective more than -2

You may qualify if:

  • Adult patients ventilated requiring sedation in ICU with RASS objective more than -2

You may not qualify if:

  • contraindication: intracranial lesion, hepatic failure
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Delirium

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jean-Michel CONSTANTIN

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2014

First Posted

July 25, 2014

Study Start

June 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

November 26, 2014

Record last verified: 2014-11

Locations

FR(1)