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The Pharmacology and Hemodynamics of Dexmedetomidine in Children With Congenital Heart Disease

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ClinicalTrials.gov Identifier: NCT00480740
Recruitment Status : Completed
First Posted : May 31, 2007
Results First Posted : June 26, 2015
Last Update Posted : June 26, 2015
Sponsor:
Information provided by (Responsible Party):
Julia Finkel, Children's Research Institute

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cardiac Transplant
Patent Ductus Arterious
Atrial Septal Defect
Bidirectional Cavopulmonary Anastomosis
Intervention Drug: Dexmedetomidine
Enrollment 41
Recruitment Details Patients were recruited from cardiology outpatient clinic. The study is anticipating to enroll 104 patients.
Pre-assignment Details 74 subjects assessed for eligibility, 9 were excluded; 12 did not meet inclusion criteria; 12 refused to enroll; resulting in 41 subjects enrolled
Arm/Group Title Normal Physiology Cardiac Transplant Fontan Physiology
Hide Arm/Group Description diagnostic cardiac catheterization in children with normal cardiac physiology diagnostic cardiac catheterization in children with a transplanted heart diagnostic cardiac catheterization in children with a transplanted ventricle
Period Title: Overall Study
Started 26 9 6
Completed 26 9 6
Not Completed 0 0 0
Arm/Group Title Normal Physiology Cardiac Transplant Fontan Physiology Total
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 26 9 6 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 9 participants 6 participants 41 participants
4.3  (4) 11  (4.5) 5.5  (3.3) 6.9  (6.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 9 participants 6 participants 41 participants
Female
17
  65.4%
3
  33.3%
2
  33.3%
22
  53.7%
Male
9
  34.6%
6
  66.7%
4
  66.7%
19
  46.3%
Weight (kg)  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 26 participants 9 participants 6 participants 41 participants
19.1  (14.3) 35.2  (17.8) 21.4  (8.7) 27.3  (13.6)
American Society of Anesthesiology (ASA) physical status classification   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants 9 participants 6 participants 41 participants
ASA 1 18 0 0 18
ASA 2 8 9 0 17
ASA 3 0 0 6 6
[1]
Measure Description: Category 1 means healthy patient Category 2 means mild systemic disease Category 3 means severe systemic disease
Primary diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants 9 participants 6 participants 41 participants
ASD 10 0 0 10
PDA 16 0 0 16
PA with IVS 0 2 0 2
HLHS 0 2 2 4
Unbalanced AVC 0 1 0 1
Cardiomyopathy 0 4 0 4
Tricuspid Atresia 0 0 2 2
DORV 0 0 1 1
Ebstein's anomaly 0 0 1 1
1.Primary Outcome
Title Changes in Hemodynamic Variables Recorded During Administration of Sevoflurane + Dexmedetomidine.
Hide Description

Non-inferiority was shown when differences at steady-state (dexmedetomidine + sevoflurane) compared to baseline (sevoflurane alone) and its associated 95% confidence interval fell completely within the range of plus or minus 20%.The 95% confidence interval was normalized by subtracting the baseline values.

Bispectral Index: monitors electroencephalographic and electromyographic parameters to monitor the depth of anesthesia.

Time Frame Up to 24 hours following cardiac catheterization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Normal Physiology Cardiac Transplant Fontan Physiology
Hide Arm/Group Description:
diagnostic cardiac catheterization in children with normal cardiac physiology
diagnostic cardiac catheterization in children with a transplanted heart
diagnostic cardiac catheterization in children with a transplanted ventricle
Overall Number of Participants Analyzed 26 9 6
Mean (95% Confidence Interval)
Unit of Measure: percentage of change from baseline
Heart Rate
-0.14
(-0.15 to -0.13)
-0.16
(-0.2 to -0.12)
-0.21
(-0.22 to -0.2)
Systolic Pressure
0.15
(0.07 to 0.23)
0.18
(0.08 to 0.28)
0.22
(0.16 to 0.28)
Diastolic Pressure
0.23
(0.13 to 0.36)
0.19
(0.13 to 0.25)
0.09
(-0.11 to 0.29)
Mean Pressure
0.23
(0.17 to 0.29)
0.16
(0.03 to 0.29)
0.08
(-0.09 to 0.25)
Bispectral Index
0.04
(-0.03 to 0.11)
0.16
(-0.11 to 0.43)
-0.14
(-0.42 to 0.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Normal Physiology, Cardiac Transplant, Fontan Physiology
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority of dexmedetomindine plus sevoflurane compared with the baseline (sevoflurane alone) for any given variable was reached when the difference (steady-state [dexmedetomidine + sevoflurane]-baseline [sevoflurane0]/baseline [sevoflurane]0 and its associated 95% confidence interval (CI) fell completely withing the range of +/-20% indicated by the gray column.
Statistical Test of Hypothesis P-Value 0.05
Comments The original study design was powered to achieve at least 80% power to detect noninferiority with the two-tailed alpha level set at 0.05 for data with two measurements.
Method t-test, 2 sided
Comments [Not Specified]
Time Frame from study start through followup
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cardiac Transplant Fontan Procedure Normal Physiology
Hide Arm/Group Description Dexmedetomidine: Dexmedetomidine load of 1 microgram/kilogram over 10 minutes, followed by a 1 microgram/kilogram/hour infusion during the time of catheterization Dexmedetomidine: Dexmedetomidine load of 1 microgram/kilogram over 10 minutes, followed by a 1 microgram/kilogram/hour infusion during the time of catheterization

control group

Dexmedetomidine: Dexmedetomidine load of 1 microgram/kilogram over 10 minutes, followed by a 1 microgram/kilogram/hour infusion during the time of catheterization

All-Cause Mortality
Cardiac Transplant Fontan Procedure Normal Physiology
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cardiac Transplant Fontan Procedure Normal Physiology
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/6 (0.00%)   0/26 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cardiac Transplant Fontan Procedure Normal Physiology
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/6 (0.00%)   0/26 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Julia Finkel
Organization: Children's National Medical Center
Phone: 202-476-4867
Responsible Party: Julia Finkel, Children's Research Institute
ClinicalTrials.gov Identifier: NCT00480740     History of Changes
Other Study ID Numbers: IRB# 3908
First Submitted: May 29, 2007
First Posted: May 31, 2007
Results First Submitted: August 19, 2014
Results First Posted: June 26, 2015
Last Update Posted: June 26, 2015