Clinical trial NCT00573066: Understanding Dexmedetomidine In Infants Post-Operative From Cardiac Surgery
Official title: The Pharmacokinetics, Pharmacogenetics, and Pharmacodynamics of Dexmedetomidine In Infants Post-Operative From Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypoplastic Left Heart
Tetralogy of Fallot
Tricuspid Atresia
Keywords: Postoperative from cardiac surgery
Dexmedetomidine
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2007-12-13
Enrollment: 56
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: PK Profile of Dexmedetomidine
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Athena Zuppa, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: