Requiring Sedation in ICUNCT02200159
Predictive Factors of Failure or Success of Sedation With Dexmedetomidine in ICU
An observational study of Requiring Sedation in ICU and Adult Patients, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Research predictive factors of success or failure of a sedation with Dexmedetomidine in ICU Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Requiring Sedation in ICU, Adult Patients, Patient Covered by French Health Care System
- What is being tested?
- Sedation with dexmedetomidine
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2014to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients ventilated requiring sedation in ICU with RASS objective more than -2
Who may be able to join
- -Adult patients ventilated requiring sedation in ICU with RASS objective more than -2
Who cannot join
- contraindication: intracranial lesion, hepatic failure
- pregnancy
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
About this study
Research predictive factors of success or failure of a sedation with Dexmedetomidine in ICU
Read the 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
- Being tested
- Sedation with dexmedetomidine
- Keywords
- Sedation, Dexmedetomidine, ICU, Delirium
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sedation with dexmedetomidineDrug
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine | Not described Receives: Drug: Sedation with dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at day 1
Secondary outcomes (2)
Incidence of adverse event of dexmedetomidine
Measured: at day 1
Incidence of delirium and use of other sedative drugs
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Requiring Sedation in ICUStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Michel CONSTANTIN, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02200159
- Sponsor's protocol ID
- CHU-0197
- Other IDs
- 2013-000960-26
- Status last verified
- Nov 2014
- First submitted
- 30 Jun 2014
- Last updated
- 26 Nov 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors of Failure or Success of Sedation With Dexmedetomidine in ICU
- ClinicalTrials.gov ID
- NCT02200159
- Acronym / sponsor ID
- CHU-0197
- Keywords
- Sedation, Dexmedetomidine, ICU, Delirium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 25 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine | – | Drug: Sedation with dexmedetomidine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients ventilated requiring sedation in ICU with RASS objective more than -2
Key inclusion criteria (1 listed)
- -Adult patients ventilated requiring sedation in ICU with RASS objective more than -2
Key exclusion criteria (2 listed)
- contraindication: intracranial lesion, hepatic failure
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sedation with dexmedetomidine | Drug | dexmedetomidine |
Primary outcome
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.
2 secondary outcomes
Incidence of adverse event of dexmedetomidine
Time frame: at day 1
Incidence of delirium and use of other sedative drugs
Time frame: at day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Michel CONSTANTIN principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Requiring Sedation in ICU and Adult Patients, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with failure of sedation with dexmedetomidine (time frame: at day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2014.