BurningDEXDORNCT02904460
Dexmedetomidine for Morphine Consumption Reduction (DEXDOR)
An observational study of Burning, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial summary
The new progresses relative to sedation-analgesia for resuscitation unit lead to perform a light and cooperative sedation as soon as possible in order to decrease the period of mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burning
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to 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: Severe burned patients cared by the Severe Burned Center between 1st January 2014 and 31 August 2015
Who may be able to join
- More than 18 years old
- Hospitalised for severe burning (total burned skin surface higher than 20% and/or smoke inhalation and/or severe comorbidities)
- Having received a continued dexmedetomidine administration of at least 24 hours for the case group and having received no dexmedetomidine administration for the control group
Who cannot join
- Inability to communicate (language barrier, major cognitive disorders)
- Medical contraindication for dexmedetomidine (hepatocellular insufficiency, hypersensibility, grade II or III atrio-ventricular blocks without device, acute brain vascular pathology).
- For the control group, pregnancy is a non-inclusion criterion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Reducting Effect of Dexmedetomidine on the Morphine Use for Severe Burned Patients
The new progresses relative to sedation-analgesia for resuscitation unit lead to perform a light and cooperative sedation as soon as possible in order to decrease the period of mechanical ventilation. Dexmedetomidine (DEX), which is a central alpha-2 agonist, is the referential hypnotic in this case with a reduction of the morphine-type use.
DEX was mainly studied in the bandage procedures for the burned adult. The aim of this study is to evaluate the reducing effect of DEX on the morphine use in case of severe burnings for adults, to describe the receivers of DEX and to report the procedure of this new molecule.
Read the detailed description
The new progresses relative to sedation-analgesia for resuscitation unit lead to perform a light and cooperative sedation as soon as possible in order to decrease the period of mechanical ventilation. Dexmedetomidine (DEX), which is a central alpha-2 agonist, is the referential hypnotic in this case with a reduction of the morphine-type use.
DEX was mainly studied in the bandage procedures for the burned adult. The aim of this study is to evaluate the reducing effect of DEX on the morphine use in case of severe burnings for adults, to describe the receivers of DEX and to report the procedure of this new molecule.
This study would manage to develop a protocol using dexmedetomidine to reduce the use of morphine for the sedation-analgesia. It expects a sensitization of physicians about the need to form the nurse crew for the autonomous use of a protocol before performing a new evaluation of sedation-analgesia.
- Conditions
- Burning
- Medical subject headings
- Paresthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
Global consumption of opioids (including per anesthesia for bandage or surgery) during the patient care period, expressed as intravenous morphine per day equivalent, indexed on the weight (mg.kg-1.j-1).
mg.kg-1.j-1
Measured: day 20
Secondary outcomes (2)
Tolerance for dexmedetomidine by hemodynamic
mm Hg
Measured: day 20
Efficiency of analgesia
RASS scale
Measured: day 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startSep 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurningStudies of the same condition, open and under way.
- 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
- Time perspective
- Retrospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Reine LOSSER, MD, Principal investigator, CHR Metz-Thionville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02904460
- Sponsor's protocol ID
- 2015-03Obs-CHRMT
- Acronym
- DEXDOR
- Status last verified
- Aug 2016
- First submitted
- 26 Aug 2016
- Last updated
- 19 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Reducting Effect of Dexmedetomidine on the Morphine Use for Severe Burned Patients
- ClinicalTrials.gov ID
- NCT02904460
- Acronym / sponsor ID
- DEXDOR / 2015-03Obs-CHRMT
- Conditions
- Burning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 19 Sep 2016 (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.
The new progresses relative to sedation-analgesia for resuscitation unit lead to perform a light and cooperative sedation as soon as possible in order to decrease the period of mechanical ventilation. Dexmedetomidine (DEX), which is a central alpha-2 agonist, is the referential hypnotic in this case with a reduction of the morphine-type use.
DEX was mainly studied in the bandage procedures for the burned adult. The aim of this study is to evaluate the reducing effect of DEX on the morphine use in case of severe burnings for adults, to describe the receivers of DEX and to report the procedure of this new molecule.
Detailed description
The new progresses relative to sedation-analgesia for resuscitation unit lead to perform a light and cooperative sedation as soon as possible in order to decrease the period of mechanical ventilation. Dexmedetomidine (DEX), which is a central alpha-2 agonist, is the referential hypnotic in this case with a reduction of the morphine-type use.
DEX was mainly studied in the bandage procedures for the burned adult. The aim of this study is to evaluate the reducing effect of DEX on the morphine use in case of severe burnings for adults, to describe the receivers of DEX and to report the procedure of this new molecule.
This study would manage to develop a protocol using dexmedetomidine to reduce the use of morphine for the sedation-analgesia. It expects a sensitization of physicians about the need to form the nurse crew for the autonomous use of a protocol before performing a new evaluation of sedation-analgesia.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Severe burned patients cared by the Severe Burned Center between 1st January 2014 and 31 August 2015
Key inclusion criteria (3 listed)
- More than 18 years old
- Hospitalised for severe burning (total burned skin surface higher than 20% and/or smoke inhalation and/or severe comorbidities)
- Having received a continued dexmedetomidine administration of at least 24 hours for the case group and having received no dexmedetomidine administration for the control group
Key exclusion criteria (3 listed)
- Inability to communicate (language barrier, major cognitive disorders)
- Medical contraindication for dexmedetomidine (hepatocellular insufficiency, hypersensibility, grade II or III atrio-ventricular blocks without device, acute brain vascular pathology).
- For the control group, pregnancy is a non-inclusion criterion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Global consumption of opioids (including per anesthesia for bandage or surgery) during the patient care period, expressed as intravenous morphine per day equivalent, indexed on the weight (mg.kg-1.j-1).
Time frame: day 20
mg.kg-1.j-1
2 secondary outcomes
Tolerance for dexmedetomidine by hemodynamic
Time frame: day 20
Efficiency of analgesia
Time frame: day 20
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 19 Sep 2016.
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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.
Marie-Reine LOSSER, MD principal investigator
CHR Metz-Thionville
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 Burning, run by Centre Hospitalier Régional Metz-Thionville 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 3 inclusion and 3 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 19 Sep 2016. 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?
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?
Global consumption of opioids (including per anesthesia for bandage or surgery) during the patient care period, expressed as intravenous morphine per day equivalent, indexed on the weight (mg.kg-1.j-1). (time frame: day 20). 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 19 Sep 2016.