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

• Sponsor: University Hospital, Clermont-Ferrand (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02200159
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Duration (Months): 18
• Patients Per Site Per Month: 11.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Requiring Sedation in ICU; Adult Patients; Patient Covered by French Health Care System	Drug: Sedation with dexmedetomidine

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 Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Cohort
• Official Title: Predictive Factors of Failure or Success of Sedation With Dexmedetomidine in ICU
• Study Start Date: Jun 1, 2014
• Anticipated Primary Completion Date: Dec 1, 2015
• Anticipated Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
dexmedetomidine	Drug: Sedation with dexmedetomidine

Outcome Measures

Primary Outcome Measures

1. 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

1. Incidence of adverse event of dexmedetomidine [at day 1]

2. Incidence of delirium and use of other sedative drugs [at day 1]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• contraindication: intracranial lesion, hepatic failure

• pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Clermont-Ferrand	Clermont-Ferrand		France	63003

Sponsors and Collaborators

• University Hospital, Clermont-Ferrand

Investigators

• Principal Investigator: Jean-Michel CONSTANTIN, University Hospital, Clermont-Ferrand

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Clermont-Ferrand
• ClinicalTrials.gov Identifier: NCT02200159
• Other Study ID Numbers: CHU-0197; 2013-000960-26
• First Posted: Jul 25, 2014
• Last Update Posted: Nov 26, 2014
• Last Verified: Nov 1, 2014

• Keywords provided by University Hospital, Clermont-Ferrand: Sedation; Dexmedetomidine; ICU; Delirium
• Additional relevant MeSH terms: Dexmedetomidine

Study Results

No Results Posted as of Nov 26, 2014