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

November 25, 2014 updated by: University Hospital, Clermont-Ferrand
Research predictive factors of success or failure of a sedation with Dexmedetomidine in ICU

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Recruiting
        • CHU de Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • contraindication: intracranial lesion, hepatic failure
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
dexmedetomidine
Drug: Sedation with dexmedetomidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with failure of sedation with dexmedetomidine
Time Frame: 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.
at day 1

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

June 30, 2014

First Submitted That Met QC Criteria

July 24, 2014

First Posted (Estimate)

July 25, 2014

Study Record Updates

Last Update Posted (Estimate)

November 26, 2014

Last Update Submitted That Met QC Criteria

November 25, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0197
  • 2013-000960-26

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Adult Patients

Clinical Trials on Sedation with dexmedetomidine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe