BurnsPhase 2NCT00697788
Dexmedetomidine Cardiovascular Safety in Pediatric Burn Patients
A Phase 2 study testing Dexmedetomidine in people with Burns and Sedation, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Dexmedetomidine is a sedative drug approved for adult patients, intubated, in intensive care units. We are studying whether this drug is cardiovascularly safe in pediatric patients who have recently been burned. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2007to 30 Dec 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- pediatric patient
- >25% total body surface area (tbsa) burn and < 90% tbsa
- opioid requirements > 0.1 mg/kg/hour of morphine (or equivalent)
- midazolam requirement > 0.1 mg/kg/hour
- treatment team determined that patient should be started on dexmedetomidine
Who cannot join
- hemodynamically unstable patients (epinephrine > 1.0 ug/kg/min, levophed > 0.75 ug/kg/min, dopamine > 10 ug/kg/min)
- pregnant patients
- patients with history of heart block
- patients with congenital heart disease
- patients with significant hepatic dysfunction
- patients with urine output < 0.5 ml/kg/hour [averaged] over past 24 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiovascular Safety of Dexmedetomidine in Pediatric Burn Patients.
Dexmedetomidine is a sedative drug approved for adult patients, intubated, in intensive care units. We are studying whether this drug is cardiovascularly safe in pediatric patients who have recently been burned.
Read the detailed description
This is an ascending dose study evaluating the cardiovascular safety of dexmedetomidine bolus/infusions in acutely burned pediatric patients. The study entails a bolus of dexmedetomidine, followed by 2 hours of increasing infusion doses. Cardiovascular parameters including EKG, heart rate, oxygen saturation, blood pressure, are recorded.
- Being tested
- Dexmedetomidine
- Keywords
- pediatric, burn, sedation
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
Dexmedetomidine bolus 1 ug/kg over 10 minutes, followed by ascending infusion as follows: Dexmedetomidine [in ug/kg/hr], each for 15 minutes: 0.7, 1.0, 1.3, 1.6, 1.9, 2.2, 2.5.
| Study group | Role | What they receive |
|---|---|---|
| Ascending dose study | Experimental | Ascending doses of dexmedetomidine (as per protocol) Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Mean Arterial Pressure (MAP)
Looking at hemodynamic response to dexmedetomidine. Mean arterial pressure primary outcome measure.
Measured: 10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration
Secondary outcomes (3)
Presence of Arrhythmias.
Presence of arrhythmias was studied using a 3 lead realtime EKG throughout study.
Measured: 10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration
Oxygen Saturation
Pulse oximetry was used to measure oxygen saturation.
Measured: 10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration
Heart Rate
Heart Rate recorded off EKG in beats per minute
Measured: 10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2008 (estimated)
- Study start16 Jul 2007
- Primary completion30 Dec 2008
- Study completion30 Dec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik S. Shank, MD, Massachusetts General Hospital
- Investigators
- Erik S Shank, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00697788
- Sponsor's protocol ID
- 2005-P-001264/1;MGH
- Status last verified
- Jun 2017
- First submitted
- 12 Jun 2008
- Last updated
- 17 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Safety of Dexmedetomidine in Pediatric Burn Patients.
- ClinicalTrials.gov ID
- NCT00697788
- Acronym / sponsor ID
- 2005-P-001264/1;MGH
- Keywords
- pediatric, burn, sedation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 16 Jul 2007 (actual)
- Primary completion
- 30 Dec 2008 (actual)
- Study completion
- 30 Dec 2008 (actual)
- First posted
- 16 Jun 2008 (estimated)
- Results
- Posted 17 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dexmedetomidine is a sedative drug approved for adult patients, intubated, in intensive care units. We are studying whether this drug is cardiovascularly safe in pediatric patients who have recently been burned.
Detailed description
This is an ascending dose study evaluating the cardiovascular safety of dexmedetomidine bolus/infusions in acutely burned pediatric patients. The study entails a bolus of dexmedetomidine, followed by 2 hours of increasing infusion doses. Cardiovascular parameters including EKG, heart rate, oxygen saturation, blood pressure, are recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ascending dose study | Experimental | Drug: DexmedetomidineAscending doses of dexmedetomidine (as per protocol) |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- pediatric patient
- >25% total body surface area (tbsa) burn and < 90% tbsa
- opioid requirements > 0.1 mg/kg/hour of morphine (or equivalent)
- midazolam requirement > 0.1 mg/kg/hour
- treatment team determined that patient should be started on dexmedetomidine
Key exclusion criteria (6 listed)
- hemodynamically unstable patients (epinephrine > 1.0 ug/kg/min, levophed > 0.75 ug/kg/min, dopamine > 10 ug/kg/min)
- pregnant patients
- patients with history of heart block
- patients with congenital heart disease
- patients with significant hepatic dysfunction
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 |
|---|---|---|
| DexmedetomidineAlso: PrecedexDexmedetomidine bolus 1 ug/kg over 10 minutes, followed by ascending infusion as follows: Dexmedetomidine [in ug/kg/hr], each for 15 minutes: 0.7, 1.0, 1.3, 1.6, 1.9, 2.2, 2.5. | Drug | Ascending dose study |
Primary outcome
Percent Change in Mean Arterial Pressure (MAP)
Time frame: 10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration
Looking at hemodynamic response to dexmedetomidine. Mean arterial pressure primary outcome measure.
3 secondary outcomes
Presence of Arrhythmias.
Time frame: 10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration
Oxygen Saturation
Time frame: 10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration
Heart Rate
Time frame: 10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Erik S Shank, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexmedetomidine in people with Burns and Sedation, run by Massachusetts General Hospital at 1 site in United States.
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 5 inclusion and 6 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 17 Jul 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change in Mean Arterial Pressure (MAP) (time frame: 10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration). 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 17 Jul 2017.