Understanding Dexmedetomidine in Neonates After Open Heart Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Athena Zuppa, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00576381
First received: December 17, 2007
Last updated: April 10, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Tetrology of Fallot
Heart Ventricle
Hypoplastic Left Heart
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 and Pharmacodynamics of Dexmedetomidine in Neonates Following Open Heart 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: 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) ] [ 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: 30
Study Start Date: April 2006
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 30 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00576381

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

No publications provided

Responsible Party: Athena Zuppa, Principal Investigator, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00576381     History of Changes
Obsolete Identifiers: NCT00516529
Other Study ID Numbers: 2006-4-4757, CTRC 2006
Study First Received: December 17, 2007
Results First Received: December 13, 2012
Last Updated: April 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Hospital of Philadelphia:
Precedex
Open Heart Surgery
Dexmedetomidine
Sedation

Additional relevant MeSH terms:
Hypoplastic Left Heart Syndrome
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
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 18, 2014