Understanding Dexmedetomidine In Infants Post-Operative From Cardiac Surgery

NCT ID: NCT00573066

Last Updated: 2013-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-31
• Study Completion Date: 2006-10-31

Brief Summary

This study is being conducted to determine what dexmedetomidine does to the body and in turn, what how the body handles the medication. This medication, for the purpose of this trial, is used as a short-term sedative for infants who are immediately post-operative from cardiac surgery and have a breathing tube and are breathing with the assistance of a mechanical ventilator or breathing machine.

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 infants who are immediately post-operative from cardiac surgery and require tracheal intubation with mechanical ventilation in the post-operative period. Three bolus doses and infusion doses will be administered to a total of 36 evaluable patients.

Conditions

Hypoplastic Left Heart; Tetralogy of Fallot; Tricuspid Atresia

Study Design

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

Study Groups

Dosing level

A predetermined dose of Dexmedetomidine

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

Dosage levels: Dose Level 1: Loading dose 0.35mcg/kg and CIVI 0.25mcg/kg/hr Dose Level 2: Loading Dose of 0.7mcg/kg and CIVI 0.5mcg/kg/hr and Dose Level 3: Loading Dose 1 mcg/kg and CIVI 0.75 mcg/kg/hr.

Interventions

Dexmedetomidine

Dosage levels: Dose Level 1: Loading dose 0.35mcg/kg and CIVI 0.25mcg/kg/hr Dose Level 2: Loading Dose of 0.7mcg/kg and CIVI 0.5mcg/kg/hr and Dose Level 3: Loading Dose 1 mcg/kg and CIVI 0.75 mcg/kg/hr.

Intervention Type: DRUG

Other Intervention Names

Precedex

Eligibility Criteria

Inclusion Criteria

• Patients must be greater or equal to one month or less than or equal to 24 months of age.
• Post operative from cardiac surgery with tracheal intubation/mechanical ventilation in the immediate post-op period.
• Planned tracheal extubation within 24 hours post-operatively.
• Adequate renal function(1-12 months old creatinine less than or equal to 0.6mg/dL and >12 months to 24 months creatinine < or= to 1.0mg/dL)
• Adequate liver function(Total bilirubin < or= 1.5mg/dL and ALT 1-12 months < or = to 165 U/L and > 12 months to 24 months < or = to 90 U/L)
• Isolated heart surgery
• Informed consent

Exclusion Criteria

• Patients who have received another investigational drug within the past 30 days.
• Receiving continuous infusions of muscle relaxants in the postoperative setting.
• Patients whoo have a positive blood culture without a subsequent negative culture or other evidence of ongoing serious infection.
• Patients, who, int he opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.
• Patients who show signs or symptoms of elevated intracranial pressure.
• Post-operative hypotension based on age.
• Preexisting bradycardia based on age.
• Heart block
• Weight < 5kg
• Patients, who in the opinion of the investigator, are not appropriate candidates for an investigational drug study.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Athena Zuppa

OTHER

Sponsor Role: lead

Responsible Party

Athena Zuppa

Attending Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Athena Zuppa, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Other Identifiers

2004-5-3770

Identifier Type: -

Identifier Source: org_study_id