Thoracic InjuriesPhase 4VENDETTANCT02537366
Dexmedetomidine for Non-invasive Ventilation After Chest Trauma
A Phase 4 study testing Dexmedetomidine in people with Thoracic Injuries, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Crossover randomized controlled double blinded trial : The primary endpoint is the duration of Non Invasive Ventilation (NIV) session (minutes) with dexmedetomidine (DEX) or placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Injuries
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to Feb 2017
- Phase
- Phase 4
- 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
Who may be able to join
- Blunt chest trauma with thoracic trauma score> 6, ICU admission and spontaneous breathing
Who cannot join
- Contra indication for NIV or Dexmedetomidine as specified by the French marketing authorization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexmedetomidine for Non-invasive Ventilation After Chest Trauma (VENDETTA)
Crossover randomized controlled double blinded trial :
- The primary endpoint is the duration of Non Invasive Ventilation (NIV) session (minutes) with dexmedetomidine (DEX) or placebo.
- Secondary endpoints will be the sedation level as assessed by the Richmond Agitation Sedation Scale (RASS), the number of interventions to allow the completion of NIV session, the pain intensity level as assessed by visual analogue scale, the morphine and ketamine consumption during NIV sessions, the comparison of blood gas measurements before and after NIV sessions, the reproducibility of NIV cycles. The side effects of DEX will be notified.
- Conditions
- Thoracic Injuries
- Being tested
- Dexmedetomidine, Placebo
- Medical subject headings
- Thoracic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Sodium Chloride 0,9 % Continuous IV infusion begun one hour before NIV session at 0.07 ml/kg/h Adaptation to sedation status by changing infusion speed of 0.02 ml/kg/h every 30 minutes up to 0.14 ml/kg/h Sedation objective Richmond Agitation Sedation Scale -3 (moderate sedation) to 0 (alert and calm) Receives: Drug: Placebo |
| DEX | Experimental | Dexmedetomidine diluted to 10 µg/ml in Sodium Chloride 0,9 % Continuous IV infusion begun one hour before NIV session at 0.7 µg/kg/h (= 0.07 ml/kg/h) Adaptation to sedation status by changing infusion speed of 0.2 µg/kg/h (= 0.02 ml/kg/h) every 30 minutes up to 1.4 µg/kg/h (= 0.14 ml/kg/h) Sedation objective Richmond Agitation Sedation Scale -3 (moderate sedation) to 0 (alert and calm) Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of NIV session
Minutes
Measured: During ICU stay (expected average of 2 weeks)
Secondary outcomes (11)
Richmond Agitation-Sedation Scale
From -5 (Unarousable) to +4 (Combative)
Measured: During ICU stay (expected average of 2 weeks)
Number of interventions on NIV settings
Measured: During ICU stay (expected average of 2 weeks)
Morphine consumption
Morphine administration during NIV session (mg/kg/h)
Measured: During ICU stay (expected average of 2 weeks)
Ketamine consumption
Ketamine administration during NIV session (mg/kg/h)
Measured: During ICU stay (expected average of 2 weeks)
Pain visual analogue scale
From 0 (no pain) to 10 (worst pain possible)
Measured: During ICU stay (expected average of 2 weeks)
Variation of arterial partial pressure of Carbon dioxide (CO2) before and after NIV session
mmHg
Measured: During ICU stay (expected average of 2 weeks)
Variation of arterial partial pressure of dioxygen (O2) before and after NIV session
mmHg
Measured: During ICU stay (expected average of 2 weeks)
Variation of potential hydrogen (pH) before and after NIV session
Measured: During ICU stay (expected average of 2 weeks)
Reproductibility of NIV sessions
Minutes
Measured: During ICU stay (expected average of 2 weeks)
Bradycardia
Mean arterial pressure less than 55 mmHg
Measured: During ICU stay (expected average of 2 weeks)
Hypotension
Heart rate less than 40 / mn
Measured: During ICU stay (expected average of 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic InjuriesStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thibaut TROUVE-BUISSON, PH, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02537366
- Sponsor's protocol ID
- EssaiClinique-VENDETTA
- Acronym
- VENDETTA
- Status last verified
- Mar 2017
- First submitted
- 21 Aug 2015
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine for Non-invasive Ventilation After Chest Trauma (VENDETTA)
- ClinicalTrials.gov ID
- NCT02537366
- Acronym / sponsor ID
- VENDETTA / EssaiClinique-VENDETTA
- Conditions
- Thoracic Injuries
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 1 Sep 2015 (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.
Crossover randomized controlled double blinded trial :
- The primary endpoint is the duration of Non Invasive Ventilation (NIV) session (minutes) with dexmedetomidine (DEX) or placebo.
- Secondary endpoints will be the sedation level as assessed by the Richmond Agitation Sedation Scale (RASS), the number of interventions to allow the completion of NIV session, the pain intensity level as assessed by visual analogue scale, the morphine and ketamine consumption during NIV sessions, the comparison of blood gas measurements before and after NIV sessions, the reproducibility of NIV cycles. The side effects of DEX will be notified.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboSodium Chloride 0,9 % Continuous IV infusion begun one hour before NIV session at 0.07 ml/kg/h Adaptation to sedation status by changing infusion speed of 0.02 ml/kg/h every 30 minutes up to 0.14 ml/kg/h Sedation objective Richmond Agitation Sedation Scale -3 (moderate sedation) to 0 (alert and calm) |
| DEX | Experimental | Drug: DexmedetomidineDexmedetomidine diluted to 10 µg/ml in Sodium Chloride 0,9 % Continuous IV infusion begun one hour before NIV session at 0.7 µg/kg/h (= 0.07 ml/kg/h) Adaptation to sedation status by changing infusion speed of 0.2 µg/kg/h (= 0.02 ml/kg/h) every 30 minutes up to 1.4 µg/kg/h (= 0.14 ml/kg/h) Sedation objective Richmond Agitation Sedation Scale -3 (moderate sedation) to 0 (alert and calm) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Blunt chest trauma with thoracic trauma score> 6, ICU admission and spontaneous breathing
Key exclusion criteria (1 listed)
- Contra indication for NIV or Dexmedetomidine as specified by the French marketing authorization
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 |
|---|---|---|
| Dexmedetomidine | Drug | DEX |
| Placebo | Drug | Placebo |
Primary outcome
Duration of NIV session
Time frame: During ICU stay (expected average of 2 weeks)
Minutes
11 secondary outcomes
Richmond Agitation-Sedation Scale
Time frame: During ICU stay (expected average of 2 weeks)
Number of interventions on NIV settings
Time frame: During ICU stay (expected average of 2 weeks)
Morphine consumption
Time frame: During ICU stay (expected average of 2 weeks)
Ketamine consumption
Time frame: During ICU stay (expected average of 2 weeks)
Pain visual analogue scale
Time frame: During ICU stay (expected average of 2 weeks)
Variation of arterial partial pressure of Carbon dioxide (CO2) before and after NIV session
Time frame: During ICU stay (expected average of 2 weeks)
Variation of arterial partial pressure of dioxygen (O2) before and after NIV session
Time frame: During ICU stay (expected average of 2 weeks)
Variation of potential hydrogen (pH) before and after NIV session
Time frame: During ICU stay (expected average of 2 weeks)
Reproductibility of NIV sessions
Time frame: During ICU stay (expected average of 2 weeks)
Bradycardia
Time frame: During ICU stay (expected average of 2 weeks)
Hypotension
Time frame: During ICU stay (expected average of 2 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
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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.
Thibaut TROUVE-BUISSON, PH principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine in people with Thoracic Injuries, run by University Hospital, Grenoble 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 1 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: finished, as of the sponsor's last update on 9 Mar 2017. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of NIV session (time frame: During ICU stay (expected average of 2 weeks)). 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 9 Mar 2017.