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Trial record 3 of 5 for:    "Tetralogy of Fallot" | "Central Nervous System Depressants"

Understanding Dexmedetomidine In Infants Post-Operative From Cardiac Surgery (InfantDex)

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ClinicalTrials.gov Identifier: NCT00573066
Recruitment Status : Completed
First Posted : December 13, 2007
Results First Posted : April 9, 2013
Last Update Posted : April 9, 2013
Sponsor:
Information provided by (Responsible Party):
Athena Zuppa, Children's Hospital of Philadelphia

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hypoplastic Left Heart
Tetralogy of Fallot
Tricuspid Atresia
Intervention Drug: Dexmedetomidine
Enrollment 56
Recruitment Details Recruitment occurred in the CHOP cardiac center during preoperative evaluation.
Pre-assignment Details All patients were evaluated postoperative to establish appropriateness for inclusion in the study.
Arm/Group Title Dexmedetomidine Dose Escalation Cohorts
Hide Arm/Group Description

Dexmedetomidine was administered to all subjects as an intravenous loading dose over 10 minutes followed by a continuous infusion for up to 24 hours.

Cohort 1--0.35mcg/kg loading dose, 0.25mcg/kg/hr infusion Cohort 2--0.7 mcg/kg loading dose, 0.5 mcg/kg/hr infusion Cohort 3--1 mcg/kg loading dose, 0.75 mcg/kg/hr infusion

Period Title: Overall Study
Started 56
Completed 36
Not Completed 20
Reason Not Completed
Exclusion criteria             18
IV malfunction             1
Postoperative bleeding             1
Arm/Group Title Dexmedetomidine, Infants, Cardiac Surgery
Hide Arm/Group Description

Pharmacologic study of dexmedetomidine in infants following cardiac surgery Dexmedetomidine was administered to all subjects as an intravenous loading dose over 10 minutes followed by a continuous infusion for up to 24 hours.

Cohort 1--0.35mcg/kg loading dose, 0.25mcg/kg/hr infusion Cohort 2--0.7 mcg/kg loading dose, 0.5 mcg/kg/hr infusion Cohort 3--1 mcg/kg loading dose, 0.75 mcg/kg/hr infusion

Overall Number of Baseline Participants 56
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants
<=18 years
56
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 56 participants
0.74  (0.42)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants
Female
24
  42.9%
Male
32
  57.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 56 participants
56
1.Primary Outcome
Title PK Profile of Dexmedetomidine
Hide Description This study measured the concentration of dex in the body and used those concentrations to determine how quickly the body metabolizes and eliminates dex(concentration-time or pharmacokinetic profile).The concentration of dex in the body is determined through serial blood sampling while administering dex and following discontinuation.
Time Frame after start of infusion (0.5, 1, 2, 4-6 hours), immediately prior to end of infusion and following end of infusion (0.25, 0.5, 1, 2, 4, 8, 12, 15-18 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
Based on an estimated inter-subject variability of 50% for steady state concentration, a sample size of 36 evaluable subjects will be sufficient to detect a difference (alpha 0.05, power 0.8) for the area under the concentration-time curve (AUC) and steady state concentration (Css) between the three dosing groups.
Arm/Group Title Dexmedetomidine, Infants, Cardiac Surgery
Hide Arm/Group Description:

Pharmacologic study of dexmedetomidine in infants following cardiac surgery Dexmedetomidine was administered to all subjects as an intravenous loading dose over 10 minutes followed by a continuous infusion for up to 24 hours.

Cohort 1--0.35mcg/kg loading dose, 0.25mcg/kg/hr infusion Cohort 2--0.7 mcg/kg loading dose, 0.5 mcg/kg/hr infusion Cohort 3--1 mcg/kg loading dose, 0.75 mcg/kg/hr infusion

Overall Number of Participants Analyzed 56
Least Squares Mean (Standard Error)
Unit of Measure: mL/min/(kg^0.75)
28  (0.08)
Time Frame Data collected for up to 30 days following end of dexmedetomidine administration
Adverse Event Reporting Description All adverse events possibly, probably and definitely related are included.
 
Arm/Group Title Dexmedetomidine, Infants, Cardiac Surgery
Hide Arm/Group Description

Pharmacologic study of dexmedetomidine in infants following cardiac surgery Dexmedetomidine was administered to all subjects as an intravenous loading dose over 10 minutes followed by a continuous infusion for up to 24 hours.

Cohort 1--0.35mcg/kg loading dose, 0.25mcg/kg/hr infusion Cohort 2--0.7 mcg/kg loading dose, 0.5 mcg/kg/hr infusion Cohort 3--1 mcg/kg loading dose, 0.75 mcg/kg/hr infusion

All-Cause Mortality
Dexmedetomidine, Infants, Cardiac Surgery
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dexmedetomidine, Infants, Cardiac Surgery
Affected / at Risk (%) # Events
Total   3/56 (5.36%)    
Cardiac disorders   
Hypotension  [1]  2/56 (3.57%)  2
Respiratory, thoracic and mediastinal disorders   
Bradypnea/Oversedation   1/56 (1.79%)  1
Indicates events were collected by systematic assessment
[1]
Post-operative blood loss
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dexmedetomidine, Infants, Cardiac Surgery
Affected / at Risk (%) # Events
Total   5/56 (8.93%)    
Cardiac disorders   
Complete heart block   1/56 (1.79%)  1
Cardiac ischemia   3/56 (5.36%)  3
Accelerated junctional rhythm   1/56 (1.79%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Athena Zuppa
Organization: Children's Hospital of Philadelphia
Phone: 267-426-7359
EMail: zuppa@email.chop.edu
Layout table for additonal information
Responsible Party: Athena Zuppa, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00573066     History of Changes
Other Study ID Numbers: 2004-5-3770
First Submitted: December 11, 2007
First Posted: December 13, 2007
Results First Submitted: March 12, 2010
Results First Posted: April 9, 2013
Last Update Posted: April 9, 2013