Understanding Dexmedetomidine In Infants Post-Operative From Cardiac Surgery

NCT00573066 | Completed Phase 1 Results DMC

• 1 other identifier: 2004-5-3770
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypoplastic Left Heart; Tetralogy of Fallot; Tricuspid Atresia

Keywords

Postoperative from cardiac surgery; Dexmedetomidine

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.

  after start of infusion (0.5, 1, 2, 4-6 hours), immediately prior to end of infusion and following end of infusion (0.25, 0.5, 1, 2, 4, 8, 12, 15-18 hours)

Study Arms (1)

Dosing level

EXPERIMENTAL

A predetermined dose of Dexmedetomidine

Drug: Dexmedetomidine

Interventions

Dexmedetomidine 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.

Also known as: Precedex

Dosing level

Eligibility Criteria

• Age: 1 Month - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Athena Zuppa: lead

MeSH Terms

Conditions

Hypoplastic Left Heart Syndrome; Tetralogy of Fallot; Tricuspid Atresia

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Valve Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Athena Zuppa
• Organization: Children's Hospital of Philadelphia

zuppa@email.chop.edu

267-426-7359

Study Officials

• Athena Zuppa, MD, MSCE

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: Attending Physician

Study Record Dates

• First Submitted: December 11, 2007
• First Posted: December 13, 2007
• Study Start: May 1, 2004
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: April 9, 2013
• Results First Posted: April 9, 2013

Record last verified: 2013-02