Back to resultsDexmedetomidine Cardiovascular Safety in Pediatric Burn Patients
Primary Purpose
Burns, Sedation
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dexmedetomidine
Sponsored by
About this trial
This is an interventional treatment trial for Burns focused on measuring pediatric, burn, sedation
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Shriners Burn Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ascending dose study
Arm Description
Ascending doses of dexmedetomidine (as per protocol)
Outcomes
Primary Outcome Measures
Percent Change in Mean Arterial Pressure (MAP)
Looking at hemodynamic response to dexmedetomidine. Mean arterial pressure primary outcome measure.
Secondary Outcome Measures
Presence of Arrhythmias.
Presence of arrhythmias was studied using a 3 lead realtime EKG throughout study.
Oxygen Saturation
Pulse oximetry was used to measure oxygen saturation.
Heart Rate
Heart Rate recorded off EKG in beats per minute
Full Information
NCT ID
NCT00697788
First Posted
June 12, 2008
Last Updated
June 19, 2017
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00697788
Brief Title
Dexmedetomidine Cardiovascular Safety in Pediatric Burn Patients
Official Title
Cardiovascular Safety of Dexmedetomidine in Pediatric Burn Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
July 16, 2007 (Actual)
Primary Completion Date
December 30, 2008 (Actual)
Study Completion Date
December 30, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns, Sedation
Keywords
pediatric, burn, sedation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ascending dose study
Arm Type
Experimental
Arm Description
Ascending doses of dexmedetomidine (as per protocol)
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent Change in Mean Arterial Pressure (MAP)
Description
Looking at hemodynamic response to dexmedetomidine. Mean arterial pressure primary outcome measure.
Time Frame
10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration
Secondary Outcome Measure Information:
Title
Presence of Arrhythmias.
Description
Presence of arrhythmias was studied using a 3 lead realtime EKG throughout study.
Time Frame
10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration
Title
Oxygen Saturation
Description
Pulse oximetry was used to measure oxygen saturation.
Time Frame
10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration
Title
Heart Rate
Description
Heart Rate recorded off EKG in beats per minute
Time Frame
10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik S Shank, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shriners Burn Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Dexmedetomidine Cardiovascular Safety in Pediatric Burn Patients
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