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
  Purpose

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.


Condition Intervention Phase
Hypoplastic Left Heart
Tetralogy of Fallot
Tricuspid Atresia
Drug: Dexmedetomidine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Pharmacokinetics, Pharmacogenetics, and Pharmacodynamics of Dexmedetomidine In Infants Post-Operative From Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • 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.


Enrollment: 56
Study Start Date: May 2004
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Precedex

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

Ages Eligible for Study:   1 Month to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00573066

Sponsors and Collaborators
Athena Zuppa
Investigators
Principal Investigator: Athena Zuppa, MD, MSCE Children's Hospital of Philadelphia
  More Information

No publications provided

Responsible Party: Athena Zuppa, Attending Physician, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00573066     History of Changes
Other Study ID Numbers: 2004-5-3770
Study First Received: December 11, 2007
Results First Received: March 12, 2010
Last Updated: February 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Hospital of Philadelphia:
Postoperative from cardiac surgery
Dexmedetomidine

Additional relevant MeSH terms:
Hypoplastic Left Heart Syndrome
Tetralogy of Fallot
Tricuspid Atresia
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Heart Valve Diseases
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 29, 2014