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Understanding Dexmedetomidine in Neonates After Open Heart Surgery (Dex)

Primary Purpose

Tetrology of Fallot, Heart Ventricle, Hypoplastic Left Heart

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dexmedetomidine
Sponsored by
Athena Zuppa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tetrology of Fallot focused on measuring Precedex, Open Heart Surgery, Dexmedetomidine, Sedation

Eligibility Criteria

1 Hour - 30 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Children's Hospital of Philadelphia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

Neonates will be administered a single bolus dose of dexmedetomidine followed by a continuous infusion for up to 24 hours post cardiac surgery.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 17, 2007
Last Updated
April 10, 2013
Sponsor
Athena Zuppa
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1. Study Identification

Unique Protocol Identification Number
NCT00576381
Brief Title
Understanding Dexmedetomidine in Neonates After Open Heart Surgery
Acronym
Dex
Official Title
The Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Neonates Following Open Heart Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Athena Zuppa

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tetrology of Fallot, Heart Ventricle, Hypoplastic Left Heart
Keywords
Precedex, Open Heart Surgery, Dexmedetomidine, Sedation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Neonates will be administered a single bolus dose of dexmedetomidine followed by a continuous infusion for up to 24 hours post cardiac surgery.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
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
Primary Outcome Measure Information:
Title
PK Profile of Dexmedetomidine
Description
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.
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
30 Days
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felice Su, MD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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Understanding Dexmedetomidine in Neonates After Open Heart Surgery

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