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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

December 11, 2007
February 28, 2013
May 2004
October 2006   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
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.
To characterize the PK profiel of Dexmedetomidine [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00573066 on ClinicalTrials.gov Archive Site
Not Provided
  • Describe the pharmacodynamic effects of dexmedetomidine [ Time Frame: 48hours ] [ Designated as safety issue: Yes ]
  • Explore the utility of non-invasive sedation monitoring through the use of a BIS monitor [ Time Frame: 24 -48 hours ] [ Designated as safety issue: Yes ]
  • Obtain preliminary pharmacogenetic data on the relationship between polymorphisms in CYP2A6 and drug response. [ Time Frame: 24-48 hours ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Understanding Dexmedetomidine In Infants Post-Operative From Cardiac Surgery
The Pharmacokinetics, Pharmacogenetics, and Pharmacodynamics of Dexmedetomidine In Infants Post-Operative From Cardiac Surgery

This study is being conducted to determine what dexmedetomidine does to the body and in turn, what how the body handles the medication. This medication, for the purpose of this trial, is used as a short-term sedative for infants who are immediately post-operative from cardiac surgery and have a breathing tube and are breathing with the assistance of a mechanical ventilator or breathing machine.

This is a single center, dose escalation study of a single bolus dose of dexmedetomidine followed by a continuous infusion for up to 24 hours in infants who are immediately post-operative from cardiac surgery and require tracheal intubation with mechanical ventilation in the post-operative period. Three bolus doses and infusion doses will be administered to a total of 36 evaluable patients.

Interventional
Phase 1
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hypoplastic Left Heart
  • Tetralogy of Fallot
  • Tricuspid Atresia
Drug: Dexmedetomidine
Dosage levels: Dose Level 1: Loading dose 0.35mcg/kg and CIVI 0.25mcg/kg/hr Dose Level 2: Loading Dose of 0.7mcg/kg and CIVI 0.5mcg/kg/hr and Dose Level 3: Loading Dose 1 mcg/kg and CIVI 0.75 mcg/kg/hr.
Other Name: Precedex
Experimental: Dosing level
A predetermined dose of Dexmedetomidine
Intervention: Drug: Dexmedetomidine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
October 2006
October 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must be greater or equal to one month or less than or equal to 24 months of age.
  • Post operative from cardiac surgery with tracheal intubation/mechanical ventilation in the immediate post-op period.
  • Planned tracheal extubation within 24 hours post-operatively.
  • Adequate renal function(1-12 months old creatinine less than or equal to 0.6mg/dL and >12 months to 24 months creatinine < or= to 1.0mg/dL)
  • Adequate liver function(Total bilirubin < or= 1.5mg/dL and ALT 1-12 months < or = to 165 U/L and > 12 months to 24 months < or = to 90 U/L)
  • Isolated heart surgery
  • Informed consent

Exclusion Criteria:

  • Patients who have received another investigational drug within the past 30 days.
  • Receiving continuous infusions of muscle relaxants in the postoperative setting.
  • Patients whoo have a positive blood culture without a subsequent negative culture or other evidence of ongoing serious infection.
  • Patients, who, int he opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.
  • Patients who show signs or symptoms of elevated intracranial pressure.
  • Post-operative hypotension based on age.
  • Preexisting bradycardia based on age.
  • Heart block
  • Weight < 5kg
  • Patients, who in the opinion of the investigator, are not appropriate candidates for an investigational drug study.
Both
1 Month to 24 Months
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00573066
2004-5-3770
Yes
Athena Zuppa, Children's Hospital of Philadelphia
Athena Zuppa
Not Provided
Principal Investigator: Athena Zuppa, MD, MSCE Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP