Understanding Dexmedetomidine in Neonates After Open Heart Surgery

NCT ID: NCT00576381

Last Updated: 2013-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2010-12-31

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.

Conditions

Tetrology of Fallot; Heart Ventricle; Hypoplastic Left Heart

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

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

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Precedex

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

• Minimum Eligible Age: 1 Hour
• Maximum Eligible Age: 30 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Athena Zuppa

OTHER

Sponsor Role: lead

Responsible Party

Athena Zuppa

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Felice Su, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

CTRC 2006

Identifier Type: -

Identifier Source: secondary_id

2006-4-4757

Identifier Type: -

Identifier Source: org_study_id

NCT00516529

Identifier Type: -

Identifier Source: nct_alias