Understanding Dexmedetomidine In Infants Post-Operative From Cardiac Surgery

Brief Title

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

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.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

PK Profile of Dexmedetomidine


Condition

Hypoplastic Left Heart

Intervention

Dexmedetomidine

Study Arms / Comparison Groups

 Dosing level
Description:  A predetermined dose of Dexmedetomidine

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

56

Start Date

May 2004

Completion Date

October 2006

Primary Completion Date

October 2006

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.
      

Gender

All

Ages

1 Month - 24 Months

Accepts Healthy Volunteers

No

Contacts

Athena Zuppa, MD, MSCE, , 



Administrative Informations


NCT ID

NCT00573066

Organization ID

2004-5-3770


Responsible Party

Sponsor-Investigator

Study Sponsor

Athena Zuppa


Study Sponsor

Athena Zuppa, MD, MSCE, Principal Investigator, Children's Hospital of Philadelphia


Verification Date

February 2013