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

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.

Study Overview

• Status: Completed
• Conditions: Tetralogy of Fallot; Tricuspid Atresia; Hypoplastic Left Heart
• Intervention / Treatment: Drug: Dexmedetomidine

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dosing level; A predetermined dose of Dexmedetomidine	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 Names: Precedex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Athena Zuppa
• Investigators: Principal Investigator: Athena Zuppa, MD, MSCE, Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start: May 1, 2004
• Primary Completion (Actual): October 1, 2006
• Study Completion (Actual): October 1, 2006

Study Registration Dates

• First Submitted: December 11, 2007
• First Submitted That Met QC Criteria: December 11, 2007
• First Posted (Estimate): December 13, 2007

Study Record Updates

• Last Update Posted (Estimate): April 9, 2013
• Last Update Submitted That Met QC Criteria: February 28, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Dexmedetomidine; Postoperative from cardiac surgery
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Valve Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Tetralogy of Fallot; Hypoplastic Left Heart Syndrome; Tricuspid Atresia; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: 2004-5-3770