Understanding Dexmedetomidine In Infants Post-Operative From Cardiac Surgery

Tetralogy of Fallot Clinical Trial

— InfantDex  

Official title:

The Pharmacokinetics, Pharmacogenetics, and Pharmacodynamics of Dexmedetomidine In Infants Post-Operative From Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00573066
• Other study ID #: 2004-5-3770
• Status: Completed
• Phase: Phase 1
• First received: December 11, 2007
• Last updated: February 28, 2013
• Start date: May 2004
• Est. completion date: October 2006

Study information

• Verified date: February 2013
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 24 Months

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypoplastic Left Heart
• Hypoplastic Left Heart Syndrome
• Tetralogy of Fallot
• Tricuspid Atresia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Athena Zuppa

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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)	No