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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ascending dose study | Experimental | Ascending doses of dexmedetomidine (as per protocol) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Mean Arterial Pressure (MAP) | Looking at hemodynamic response to dexmedetomidine. Mean arterial pressure primary outcome measure. | 10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of Arrhythmias. | Presence of arrhythmias was studied using a 3 lead realtime EKG throughout study. | 10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration |
| Oxygen Saturation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erik S Shank, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shriners Burn Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Dexmedetomidine Bolus 1 mcg/kg Over 10 Min IV | All participants received a dexmedetomidine bolus of 1.0 micrograms (mcg) per kilogram over 10 minutes. |
| FG001 | Cohort 2: Dexmedetomidine 0.7 mcg/kg/hr Infusion | This group received the bolus dose and a continuous infusion for 15 minutes of 0.7 mcg/kg/hr of dexmedetomidine. This group is a subset of Cohort 1 that continued in this ascending dose study. |
| FG002 | Cohort 3: Dexmedetomidine 1.0 mcg/kg/hr Infusion | This group received the bolus dose, followed by dexmedetomidine infusion for 15 minutes at 0.7 mcg/kg/hr, followed by 1.0 mcg/kg/hr infusion for 15 minutes. This is a subset of cohort 2. |
| FG003 | Cohort 4: Dexmedetomidine Infusion 1.3 mcg/kg/hr | This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes. This group is a subset of cohort 3. |
| FG004 | Cohort 5: Dexmedetomidine 1.6 mcg/kg/hr Infusion | This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes, followed by 1.6 mcg/kg/hr for 15 minutes. This group is a subset of cohort 4. |
| FG005 | Cohort 6: Dexmedetomidine 1.9 mcg/kg/hr | This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes, followed by 1.6 mcg/kg/hr for 15 minutes, followed by 1.9 mcg/kg/hr for 15 minutes. This group is a subset of cohort 5. |
| FG006 | Cohort 7: Dexmedetomidine 2.2 mcg/kg/hr | This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes, followed by 1.6 mcg/kg/hr for 15 minutes, followed by 1.9 mcg/kg/hr for 15 minutes, followed by 2.2 mcg/kg/hr over 15 minutes. This group is a subset of cohort 6. |
| FG007 | Cohort 8: Dexmedetomidine 2.5 mcg/kg/hr | This group received the bolus dose followed by the ascending infusion first at 0.7 mcg/kg/hr for 15 minutes, then 1.0 mcg/kg/hr for 15 minutes, the 1.3 mcg/kg.hr for 15 minutes, followed by 1.6 mcg/kg/hr for 15 minutes, followed by 1.9 mcg/kg/hr for 15 minutes, followed by 2.2 mcg/kg/hr over 15 minutes, followed by 2.5 mcg/kg/hr over 15 minutes. This group is a subset of cohort 7. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dexmedetomidine Bolus 1 mcg/kg |
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| Dexmedetomidine 0.7 mcg/kg/hr Infusion |
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| Dexmedetomidine 1.0 mcg/kg/hr Infusion |
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| Dexmedetomidine 1.3 mcg.kg/hr Infusion |
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| Dexmedetomidine 1.6 mcg.kg.hr Infusion |
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| Dexmedetomidine 1.9 mcg/kg/hr Infusion |
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| Dexmedetomidine 2.2 mcg/kg/hr Infusion |
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| Dexmedetomidine 2.5 mcg/kg/hr Infusion |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ascending Dose Study | Ascending doses of dexmedetomidine (as per protocol) Dexmedetomidine: 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change in Mean Arterial Pressure (MAP) | Looking at hemodynamic response to dexmedetomidine. Mean arterial pressure primary outcome measure. | Acutely burned pediatric patients intubated with burns >=20% between 2 and 19 years of age requiring escalating doses of morphine and midazolam | Posted | Mean | Standard Deviation | % change | 10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration |
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Data was collected for the two hour period of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: Dexmedetomidine Bolus 1 mcg/kg Over 10 Min IV | All participants received a dexmedetomidine bolus dose of 1 microgram/kilogram over 10 minutes IV |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Significant hypotension defined as mean arterial pressure <50 mm Hg | Vascular disorders | hypotension | Non-systematic Assessment | Hypotension, defined as mean arterial pressure (MAP) < 50 millimeters of mercury, was considered an adverse event and would halt the ascending dose study for the subject. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erik Shank, MD | Mass General Hospital for Children | 6177242250 | eshank@partners.org |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Pulse oximetry was used to measure oxygen saturation.
| 10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration |
| Heart Rate | Heart Rate recorded off EKG in beats per minute | 10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Total Body Surface Area Burned | Mean | Standard Deviation | percentage of surface |
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| Weight | Mean | Standard Deviation | kilograms |
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| Central Venous Pressure | Mean | Standard Deviation | millimeters of mercury (mm Hg) |
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| Time after injury in days | Mean | Standard Deviation | days |
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| Fluid intake-Fluid output | Mean | Standard Deviation | ml/kg/24 hours |
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| OG003 | Cohort 4: Dexmedetomidine Infusion 1.3 mcg/kg/hr |
| OG004 | Cohort 5: Dexmedetomidine 1.6 mcg/kg/hr Infusion |
| OG005 | Cohort 6: Dexmedetomidine 1.9 mcg/kg/hr |
| OG006 | Cohort 7: Dexmedetomidine 2.2 mcg/kg/hr |
| OG007 | Cohort 8: Dexmedetomidine 2.5 mcg/kg/hr |
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| Secondary | Presence of Arrhythmias. | Presence of arrhythmias was studied using a 3 lead realtime EKG throughout study. | EKG was analyzed on each participant looking for presence of arrhythmias. None were detected. | Posted | Count of Participants | Participants | 10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration |
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| Secondary | Oxygen Saturation | Pulse oximetry was used to measure oxygen saturation. | Posted | Mean | Standard Deviation | Percent of Hemoglobin Saturated | 10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration |
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| Secondary | Heart Rate | Heart Rate recorded off EKG in beats per minute | Posted | Mean | Standard Deviation | heart beats per minute | 10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration |
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| 0 |
| 8 |
| 0 |
| 8 |
| 1 |
| 8 |
| EG001 | Cohort 2: Dexmedetomidine 0.7 mcg/kg/hr Infusion | This group received the bolus dose and then an infusion of 0.7 mcg/kg/hr for 15 minutes | 0 | 7 | 0 | 7 | 2 | 7 |
| EG002 | Cohort 3: Dexmedetomidine 1.0 mcg/kg/hr Infusion | This group received the bolus dose and then an infusion of 0.7 mcg/kg/hr for 15 minutes, followed by 1.0 mcg/kg/hr over 15 minutes | 0 | 4 | 0 | 4 | 0 | 4 |
| EG003 | Cohort 4: Dexmedetomidine 1.3 mcg/kg/hr Infusion | This group received the bolus dose and then an infusion of 0.7 mcg/kg/hr for 15 minutes, followed by 1.0 mcg/kg/hr over 15 minutes, followed by 1.3 mcg/kg/hr | 0 | 4 | 0 | 4 | 0 | 4 |
| EG004 | Cohort 5: Dexmedetomidine 1.6 mcg/kg/hr Infusion | This group received the bolus dose and then an infusion of 0.7 mcg/kg/hr for 15 minutes, followed by 1.0 mcg/kg/hr over 15 minutes, followed by 1.3 mcg/kg/hr, followed by 1.6 mcg/kg/hr over 15 minutes | 0 | 4 | 0 | 4 | 0 | 4 |
| EG005 | Cohort 6: Dexmedetomidine 1.9 mcg/kg/hr Infusion | This group received the bolus dose and then an infusion of 0.7 mcg/kg/hr for 15 minutes, followed by 1.0 mcg/kg/hr over 15 minutes, followed by 1.3 mcg/kg/hr, followed by 1.6 mcg/kg/hr over 15 minutes, followed by 1.9 mcg/kg/hr over 15 minutes | 0 | 3 | 0 | 3 | 0 | 3 |
| EG006 | Cohort 7: Dexmedetomidine 2.2 mcg/kg/hr Infusion | This group received the bolus dose and then an infusion of 0.7 mcg/kg/hr for 15 minutes, followed by 1.0 mcg/kg/hr over 15 minutes, followed by 1.3 mcg/kg/hr, followed by 1.6 mcg/kg/hr over 15 minutes, followed by 1.9 mcg/kg/hr over 15 minutes, followed by 2.2 mcg/kg/hr over 15 minutes | 0 | 3 | 0 | 3 | 0 | 3 |
| EG007 | Cohort 8: Dexmedetomidine 2.5 mcg/kg/hr Infusion | This group received the bolus dose and then an infusion of 0.7 mcg/kg/hr for 15 minutes, followed by 1.0 mcg/kg/hr over 15 minutes, followed by 1.3 mcg/kg/hr, followed by 1.6 mcg/kg/hr over 15 minutes, followed by 1.9 mcg/kg/hr over 15 minutes, followed by 2.2 mcg/kg/hr over 15 minutes, followed by 2.5 mcg/kg/hr over 15 minutes | 0 | 2 | 0 | 2 | 0 | 2 |
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