NCT00576381

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2006

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 19, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

April 11, 2013

Completed
Last Updated

April 18, 2013

Status Verified

April 1, 2013

Enrollment Period

4.7 years

First QC Date

December 17, 2007

Results QC Date

December 13, 2012

Last Update Submit

April 10, 2013

Conditions

Tetrology of FallotHeart VentricleHypoplastic Left Heart

Keywords

PrecedexOpen Heart SurgeryDexmedetomidineSedation

Outcome Measures

Primary Outcomes (1)

  • 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.

    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)

Study Arms (1)

A

EXPERIMENTAL

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

Interventions

DexmedetomidineDRUG

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

Also known as: Precedex
A

Eligibility Criteria

Age1 Hour - 30 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Tetralogy of FallotHypoplastic Left Heart Syndrome

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr Athena Zuppa
Organization
The Children's Hospital of Philadelphia
zuppa@email.chop.edu
267-426-5753

Study Officials

  • Felice Su, MD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 17, 2007

First Posted

December 19, 2007

Study Start

April 1, 2006

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

April 18, 2013

Results First Posted

April 11, 2013

Record last verified: 2013-04

Locations

US(1)