Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
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.
 
ClinicalTrials.gov Identifier: NCT00576381
Recruitment Status : Completed
First Posted : December 19, 2007
Results First Posted : April 11, 2013
Last Update Posted : April 18, 2013
Sponsor:
Information provided by (Responsible Party):
Athena Zuppa, Children's Hospital of Philadelphia

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Tetrology of Fallot
Heart Ventricle
Hypoplastic Left Heart
Intervention Drug: Dexmedetomidine
Enrollment 30
Recruitment Details All subjects were recruited from inpatient cardiac intensive care unit prior to open heart surgery.
Pre-assignment Details  
Arm/Group Title Neonatal Dose Escalation Cohorts
Hide Arm/Group Description

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

Cohort 1--0.25 mcg/kg loading dose, 0.2 mcg/kg/hr infusion Cohort 1A--0.35 mcg/kg loading dose, 0.3 mcg/kg/hr infusion Cohort 2--0.5 mcg/kg loading dose, 0.4 mcg/kg/hr infusion

Period Title: Overall Study
Started 30
Completed 23
Not Completed 7
Reason Not Completed
Reoperation             3
Adverse Event             4
Arm/Group Title Dosing Cohorts
Hide Arm/Group Description

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

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

Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
30
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
14
  46.7%
Male
16
  53.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
1.Primary Outcome
Title PK Profile of Dexmedetomidine
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Based on an estimated inter-subject variability of 50% for clearance, a sample size of 32 evaluable subjects will be sufficient to detect an 18% difference (alpha 0.05, power 0.9) in the clearance in this population (38 + 18 L/hr) versus that previously reported in the adult population (46 L/hr).
Arm/Group Title Neonates
Hide Arm/Group Description:

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

Cohort 1--0.25mcg/kg loading dose, 0.2mcg/kg/hr infusion Cohort 1A--0.35 mcg/kg loading dose, 0.3 mcg/kg/hr infusion Cohort 2--0.5 mcg/kg loading dose, 0.4 mcg/kg/hr infusion

Overall Number of Participants Analyzed 30
Least Squares Mean (Standard Error)
Unit of Measure: mL/min
110  (6.24)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dosing Cohorts
Hide Arm/Group Description

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

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

All-Cause Mortality
Dosing Cohorts
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dosing Cohorts
Affected / at Risk (%) # Events
Total   2/30 (6.67%)    
Cardiac disorders   
Atrial ectopy  2/30 (6.67%)  2
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dosing Cohorts
Affected / at Risk (%) # Events
Total   3/30 (10.00%)    
Cardiac disorders   
myocardial ischemia  1/30 (3.33%)  1
accelerated junctional rhythm  2/30 (6.67%)  2
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Athena Zuppa
Organization: The Children's Hospital of Philadelphia
Phone: 267-426-5753
EMail: zuppa@email.chop.edu
Layout table for additonal information
Responsible Party: Athena Zuppa, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00576381     History of Changes
Obsolete Identifiers: NCT00516529
Other Study ID Numbers: 2006-4-4757
CTRC 2006
First Submitted: December 17, 2007
First Posted: December 19, 2007
Results First Submitted: December 13, 2012
Results First Posted: April 11, 2013
Last Update Posted: April 18, 2013