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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Athena Zuppa, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00573066
First received: December 11, 2007
Last updated: February 28, 2013
Last verified: February 2013
Results First Received: March 12, 2010  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Hypoplastic Left Heart
Tetralogy of Fallot
Tricuspid Atresia
Intervention: Drug: Dexmedetomidine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment occurred in the CHOP cardiac center during preoperative evaluation.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All patients were evaluated postoperative to establish appropriateness for inclusion in the study.

Reporting Groups
  Description
Dexmedetomidine Dose Escalation Cohorts

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


Participant Flow:   Overall Study
    Dexmedetomidine Dose Escalation Cohorts  
STARTED     56  
COMPLETED     36  
NOT COMPLETED     20  
Exclusion criteria                 18  
IV malfunction                 1  
Postoperative bleeding                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Dexmedetomidine, Infants, Cardiac Surgery

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


Baseline Measures
    Dexmedetomidine, Infants, Cardiac Surgery  
Number of Participants  
[units: participants]
  56  
Age  
[units: participants]
 
<=18 years     56  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  0.74  ± 0.42  
Gender  
[units: participants]
 
Female     24  
Male     32  
Region of Enrollment  
[units: participants]
 
United States     56  



  Outcome Measures

1.  Primary:   PK Profile of Dexmedetomidine   [ 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) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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:  
Name/Title: Athena Zuppa
Organization: Children's Hospital of Philadelphia
phone: 267-426-7359
e-mail: zuppa@email.chop.edu


No publications provided


Responsible Party: Athena Zuppa, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00573066     History of Changes
Other Study ID Numbers: 2004-5-3770
Study First Received: December 11, 2007
Results First Received: March 12, 2010
Last Updated: February 28, 2013
Health Authority: United States: Food and Drug Administration