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

• Conditions: Requiring Sedation in ICU; Patient Covered by French Health Care System; Adult Patients
• Interventions: Drug: Sedation with dexmedetomidine

• Registration Number: NCT02200159
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-30
• Study First Submitted QC: 2014-07-24
• Study First Posted: 2014-07-25
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-25
• Last Update Posted: 2014-11-26
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
dexmedetomidine	Sedation with dexmedetomidine	-

Primary Outcome Measures

Name	Time	Method
Number of patients with failure of sedation with dexmedetomidine	at day 1	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse event of dexmedetomidine	at day 1
Incidence of delirium and use of other sedative drugs	at day 1

Trial Locations

Locations (1)

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France