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Trial record 4 of 5 for:    "Tetralogy of Fallot" | "Central Nervous System Depressants"

Understanding Dexmedetomidine in Neonates After Open Heart Surgery (Dex)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00576381
Recruitment Status : Completed
First Posted : December 19, 2007
Results First Posted : April 11, 2013
Last Update Posted : April 18, 2013
Information provided by (Responsible Party):
Athena Zuppa, Children's Hospital of Philadelphia

Brief Summary:
The purpose of this study is to determine what happens to dexmedetomidine in the body after it has been given to a newborn after heart surgery. We want to learn how long the drug stays in the body, how the drug is metabolized by the body, and how well the medicine works at a particular dose or amount.

Condition or disease Intervention/treatment Phase
Tetrology of Fallot Heart Ventricle Hypoplastic Left Heart Drug: Dexmedetomidine Phase 1

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 neonates who are immediately post-op from cardiac surgery, and require tracheal intubation with mechanical ventilation in the post-op period.

Pediatric populations may benefit from the favorable pharmacodynamic effects of this medication.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Neonates Following Open Heart Surgery
Study Start Date : April 2006
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Arm Intervention/treatment
Experimental: A
Neonates will be administered a single bolus dose of dexmedetomidine followed by a continuous infusion for up to 24 hours post cardiac surgery.
Drug: Dexmedetomidine
Dosage Level 1=0.25mcg/kg loading dose, 0.2 mcg/kg/hr infusion Dosage Level 1A= 0.35mcg/kg loading dose, 0.3 mcg/kg/hr infusion Dosage Level 2= 0.5mcg/kg loading dose, 0.4 mcg/kg/hr infusion
Other Name: Precedex

Primary Outcome Measures :
  1. PK Profile of Dexmedetomidine [ Time Frame: A sparse PK sampling method was utilized. Between 6-12 PK samples were drawn : After start of infusion (0.5, 4-6, 8 hours), immediately prior to end of infusion and following end of infusion (0.25, 0.5, 1, 2-4, 6-8, 10-12 & 18hrs) ]
    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.

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Ages Eligible for Study:   up to 30 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must be less than or equal to 1 month old.
  • Postconceptual age must be > or equal to 37 weeks on the day of surgery.
  • Postoperative from cardiac surgery with tracheal intubation/mechanical ventilation in the immediate post-op period.
  • Planned tracheal extubation within 24 hrs post-op.
  • Adequate renal function (serum creatine < or equal to 1.5mg/dL)
  • Adequate liver function (ALT < or equal to 165 U/L)
  • Isolated heart surgery
  • Informed consent

Exclusion Criteria:

  • Patients who have received another investigational drug since birth.
  • Patients receiving continuous infusions of muscle relaxants in the post-op setting.
  • Pateints who have a positive blood culture without a subsequent negative culture of other evidence of ongoing serious infection.
  • Patients who show signs and symptoms of elevated intracranial pressure.
  • Post-op hypotension defined by post conceptual age.
  • Pre-existing bradycardia defined by age
  • Heart block
  • Weight < 2kg
  • Patients who, in the opinion of the investigator, are not appropriate candidates for an investigational drug study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00576381

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United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Athena Zuppa
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Principal Investigator: Felice Su, MD Children's Hospital of Philadelphia

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Responsible Party: Athena Zuppa, Principal Investigator, Children's Hospital of Philadelphia Identifier: NCT00576381     History of Changes
Obsolete Identifiers: NCT00516529
Other Study ID Numbers: 2006-4-4757
CTRC 2006
First Posted: December 19, 2007    Key Record Dates
Results First Posted: April 11, 2013
Last Update Posted: April 18, 2013
Last Verified: April 2013
Keywords provided by Athena Zuppa, Children's Hospital of Philadelphia:
Open Heart Surgery
Additional relevant MeSH terms:
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Tetralogy of Fallot
Central Nervous System Depressants
Hypoplastic Left Heart Syndrome
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Hypnotics and Sedatives
Physiological Effects of Drugs
Analgesics, Non-Narcotic
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