Back to resultsUnderstanding Dexmedetomidine In Infants Post-Operative From Cardiac Surgery (InfantDex)
Primary Purpose
Hypoplastic Left Heart, Tetralogy of Fallot, Tricuspid Atresia
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Dexmedetomidine
Sponsored by
About this trial
This is an interventional treatment trial for Hypoplastic Left Heart focused on measuring Postoperative from cardiac surgery, Dexmedetomidine
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dosing level
Arm Description
A predetermined dose of Dexmedetomidine
Outcomes
Primary Outcome Measures
PK Profile of Dexmedetomidine
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00573066
Brief Title
Understanding Dexmedetomidine In Infants Post-Operative From Cardiac Surgery
Acronym
InfantDex
Official Title
The Pharmacokinetics, Pharmacogenetics, and Pharmacodynamics of Dexmedetomidine In Infants Post-Operative From Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Athena Zuppa
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoplastic Left Heart, Tetralogy of Fallot, Tricuspid Atresia
Keywords
Postoperative from cardiac surgery, Dexmedetomidine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dosing level
Arm Type
Experimental
Arm Description
A predetermined dose of Dexmedetomidine
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
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.
Primary Outcome Measure Information:
Title
PK Profile of Dexmedetomidine
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Athena Zuppa, MD, MSCE
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Understanding Dexmedetomidine In Infants Post-Operative From Cardiac Surgery
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