Understanding Dexmedetomidine in Neonates After Open Heart Surgery

Hypoplastic Left Heart Clinical Trial

— Dex  

Official title:

The Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Neonates Following Open Heart Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00576381
• Other study ID #: 2006-4-4757
• Secondary ID: CTRC 2006
• Status: Completed
• Phase: Phase 1
• First received: December 17, 2007
• Last updated: April 10, 2013
• Start date: April 2006
• Est. completion date: December 2010

Study information

• Verified date: April 2013
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00516529

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 30 Days

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Ventricle
• Hypoplastic Left Heart
• Hypoplastic Left Heart Syndrome
• Tetralogy of Fallot
• Tetrology of Fallot

Intervention

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

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Athena Zuppa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No