Trial Outcomes & Findings for Dexmedetomidine Cardiovascular Safety in Pediatric Burn Patients (NCT NCT00697788)

NCT ID: NCT00697788

Last Updated: 2017-07-17

Results Overview

Looking at hemodynamic response to dexmedetomidine. Mean arterial pressure primary outcome measure.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration

Results posted on

2017-07-17

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.	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.	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.	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.	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.	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.	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.
Dexmedetomidine Bolus 1 mcg/kg STARTED	8	0	0	0	0	0	0	0
Dexmedetomidine Bolus 1 mcg/kg COMPLETED	8	0	0	0	0	0	0	0
Dexmedetomidine Bolus 1 mcg/kg NOT COMPLETED	0	0	0	0	0	0	0	0
Dexmedetomidine 0.7 mcg/kg/hr Infusion STARTED	0	7	0	0	0	0	0	0
Dexmedetomidine 0.7 mcg/kg/hr Infusion COMPLETED	0	5	0	0	0	0	0	0
Dexmedetomidine 0.7 mcg/kg/hr Infusion NOT COMPLETED	0	2	0	0	0	0	0	0
Dexmedetomidine 1.0 mcg/kg/hr Infusion STARTED	0	0	3	0	0	0	0	0
Dexmedetomidine 1.0 mcg/kg/hr Infusion COMPLETED	0	0	3	0	0	0	0	0
Dexmedetomidine 1.0 mcg/kg/hr Infusion NOT COMPLETED	0	0	0	0	0	0	0	0
Dexmedetomidine 1.3 mcg.kg/hr Infusion STARTED	0	0	0	3	0	0	0	0
Dexmedetomidine 1.3 mcg.kg/hr Infusion COMPLETED	0	0	0	3	0	0	0	0
Dexmedetomidine 1.3 mcg.kg/hr Infusion NOT COMPLETED	0	0	0	0	0	0	0	0
Dexmedetomidine 1.6 mcg.kg.hr Infusion STARTED	0	0	0	0	3	0	0	0
Dexmedetomidine 1.6 mcg.kg.hr Infusion COMPLETED	0	0	0	0	2	0	0	0
Dexmedetomidine 1.6 mcg.kg.hr Infusion NOT COMPLETED	0	0	0	0	1	0	0	0
Dexmedetomidine 1.9 mcg/kg/hr Infusion STARTED	0	0	0	0	0	2	0	0
Dexmedetomidine 1.9 mcg/kg/hr Infusion COMPLETED	0	0	0	0	0	2	0	0
Dexmedetomidine 1.9 mcg/kg/hr Infusion NOT COMPLETED	0	0	0	0	0	0	0	0
Dexmedetomidine 2.2 mcg/kg/hr Infusion STARTED	0	0	0	0	0	0	2	0
Dexmedetomidine 2.2 mcg/kg/hr Infusion COMPLETED	0	0	0	0	0	0	2	0
Dexmedetomidine 2.2 mcg/kg/hr Infusion NOT COMPLETED	0	0	0	0	0	0	0	0
Dexmedetomidine 2.5 mcg/kg/hr Infusion STARTED	0	0	0	0	0	0	0	2
Dexmedetomidine 2.5 mcg/kg/hr Infusion COMPLETED	0	0	0	0	0	0	0	2
Dexmedetomidine 2.5 mcg/kg/hr Infusion NOT COMPLETED	0	0	0	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.	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.	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.	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.	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.	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.
Dexmedetomidine 0.7 mcg/kg/hr Infusion Physician Decision	0	2	0	0	0	0	0	0
Dexmedetomidine 1.6 mcg.kg.hr Infusion Physician Decision	0	0	0	0	1	0	0	0

Baseline Characteristics

Dexmedetomidine Cardiovascular Safety in Pediatric Burn Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ascending Dose Study n=8 Participants 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.
Age, Categorical <=18 years	8 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants
Total Body Surface Area Burned	58.3 percentage of surface STANDARD_DEVIATION 15.2 • n=5 Participants
Weight	33.5 kilograms STANDARD_DEVIATION 23.5 • n=5 Participants
Central Venous Pressure	10.4 millimeters of mercury (mm Hg) STANDARD_DEVIATION 4 • n=5 Participants
Time after injury in days	19.7 days STANDARD_DEVIATION 10.3 • n=5 Participants
Fluid intake-Fluid output	88.7 ml/kg/24 hours STANDARD_DEVIATION 71.8 • n=5 Participants

PRIMARY outcome

Timeframe: 10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration

Population: Acutely burned pediatric patients intubated with burns \>=20% between 2 and 19 years of age requiring escalating doses of morphine and midazolam

Looking at hemodynamic response to dexmedetomidine. Mean arterial pressure primary outcome measure.

Outcome measures

Outcome measures
Measure	Cohort 1: Dexmedetomidine Bolus 1 mcg/kg Over 10 Min IV n=8 Participants	Cohort 2: Dexmedetomidine Bolus + 0.7 mcg/kg/hr Infusion n=5 Participants	Cohort 3: Dexmedetomidine 1.0 mcg/kg/hr Infusion n=4 Participants	Cohort 4: Dexmedetomidine Infusion 1.3 mcg/kg/hr n=4 Participants	Cohort 5: Dexmedetomidine 1.6 mcg/kg/hr Infusion n=4 Participants	Cohort 6: Dexmedetomidine 1.9 mcg/kg/hr n=3 Participants	Cohort 7: Dexmedetomidine 2.2 mcg/kg/hr n=3 Participants	Cohort 8: Dexmedetomidine 2.5 mcg/kg/hr n=3 Participants
Percent Change in Mean Arterial Pressure (MAP)	26.7 % change Standard Deviation 7.5	30.8 % change Standard Deviation 10.2	26.5 % change Standard Deviation 10.5	24.5 % change Standard Deviation 13.8	25.5 % change Standard Deviation 12.5	18 % change Standard Deviation 8.7	15 % change Standard Deviation 7	15.6 % change Standard Deviation 8.0

SECONDARY outcome

Timeframe: 10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration

Population: EKG was analyzed on each participant looking for presence of arrhythmias. None were detected.

Presence of arrhythmias was studied using a 3 lead realtime EKG throughout study.

Outcome measures

Outcome measures
Measure	Cohort 1: Dexmedetomidine Bolus 1 mcg/kg Over 10 Min IV n=8 Participants	Cohort 2: Dexmedetomidine Bolus + 0.7 mcg/kg/hr Infusion n=5 Participants	Cohort 3: Dexmedetomidine 1.0 mcg/kg/hr Infusion n=4 Participants	Cohort 4: Dexmedetomidine Infusion 1.3 mcg/kg/hr n=4 Participants	Cohort 5: Dexmedetomidine 1.6 mcg/kg/hr Infusion n=4 Participants	Cohort 6: Dexmedetomidine 1.9 mcg/kg/hr n=3 Participants	Cohort 7: Dexmedetomidine 2.2 mcg/kg/hr n=3 Participants	Cohort 8: Dexmedetomidine 2.5 mcg/kg/hr n=3 Participants
Presence of Arrhythmias.	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration

Pulse oximetry was used to measure oxygen saturation.

Outcome measures

Outcome measures
Measure	Cohort 1: Dexmedetomidine Bolus 1 mcg/kg Over 10 Min IV n=8 Participants	Cohort 2: Dexmedetomidine Bolus + 0.7 mcg/kg/hr Infusion n=5 Participants	Cohort 3: Dexmedetomidine 1.0 mcg/kg/hr Infusion n=4 Participants	Cohort 4: Dexmedetomidine Infusion 1.3 mcg/kg/hr n=4 Participants	Cohort 5: Dexmedetomidine 1.6 mcg/kg/hr Infusion n=4 Participants	Cohort 6: Dexmedetomidine 1.9 mcg/kg/hr n=3 Participants	Cohort 7: Dexmedetomidine 2.2 mcg/kg/hr n=3 Participants	Cohort 8: Dexmedetomidine 2.5 mcg/kg/hr n=3 Participants
Oxygen Saturation	99.8 Percent of Hemoglobin Saturated Standard Deviation 0.5	99.5 Percent of Hemoglobin Saturated Standard Deviation 0.8	99.5 Percent of Hemoglobin Saturated Standard Deviation 0.8	98.6 Percent of Hemoglobin Saturated Standard Deviation 1.1	98.6 Percent of Hemoglobin Saturated Standard Deviation 1.1	98.6 Percent of Hemoglobin Saturated Standard Deviation 1.3	99.3 Percent of Hemoglobin Saturated Standard Deviation 1.5	99.5 Percent of Hemoglobin Saturated Standard Deviation 0.6

SECONDARY outcome

Timeframe: 10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration

Heart Rate recorded off EKG in beats per minute