Predictive Factors of Failure or Success of Sedation With... | NCT02200159

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

NCT02200159

Sponsor

University Hospital, Clermont-Ferrand

Status

Unknown status

Last Update Posted

Nov 26, 2014Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

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

Interventions

Sedation with dexmedetomidine

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2013-000960-26

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Dec 2015Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Jun 30, 2014

First Submission Date that Met QC Criteria

Jul 24, 2014

First Posted Date

Jul 25, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 25, 2014

Last Update Posted Date

Nov 26, 2014Estimated

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Label	Type	Description	Intervention Names
dexmedetomidine			Drug: Sedation with dexmedetomidine

Name	Type	Description	Arm Group Labels	Other Names
Sedation with dexmedetomidine	Drug		dexmedetomidine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Incidence of adverse event of dexmedetomidine		at day 1
Incidence of delirium and use of other sedative drugs		at day 1

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

contraindication: intracranial lesion, hepatic failure
pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Patrick LACARIN	Contact	04 73 75 11 95		placarin@chu-clermontferrand.fr

Overall Officials

Name	Affiliation	Role
Jean-Michel CONSTANTIN	University Hospital, Clermont-Ferrand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Clermont-Ferrand	Recruiting	Clermont-Ferrand		63003	France

Condition Browse Module

MeSH Terms

ID	Term
D003693	Delirium

Ancestor Terms

ID	Term
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020927	Dexmedetomidine

Ancestor Terms

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided