Predictive Factors of Failure or Success of Sedation With Dexmedetomidine in ICU

Adult Patients Clinical Trial

Official title:

Predictive Factors of Failure or Success of Sedation With Dexmedetomidine in ICU

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02200159
• Other study ID #: CHU-0197
• Secondary ID: 2013-000960-26
• Status: Recruiting
• Phase: N/A
• First received: June 30, 2014
• Last updated: November 25, 2014
• Start date: June 2014
• Est. completion date: December 2015

Study information

• Verified date: November 2014
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial Summary

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

Description:

Prospective clinical study in ICU with sedated ventilated patients with dexmedetomidine, establishing incidence of success, failure of moderate sedation or failure of dexmedetomidine, to evaluate the effectiveness of this drug sedation in moderate sedation

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• contraindication: intracranial lesion, hepatic failure

• pregnancy

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Adult Patients
• Patient Covered by French Health Care System
• Requiring Sedation in ICU

Intervention

Drug:
• Sedation with dexmedetomidine

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Incidence of adverse event of dexmedetomidine		at day 1	No
Secondary	Incidence of delirium and use of other sedative drugs		at day 1	No