Understanding Dexmedetomidine In Infants Post-Operative From Cardiac Surgery (InfantDex)
This study has been completed.
Sponsor:
Athena Zuppa
Information provided by (Responsible Party):
Athena Zuppa, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00573066
First received: December 11, 2007
Last updated: February 28, 2013
Last verified: February 2013
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypoplastic Left Heart Tetralogy of Fallot Tricuspid Atresia |
Drug: Dexmedetomidine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Pharmacokinetics, Pharmacogenetics, and Pharmacodynamics of Dexmedetomidine In Infants Post-Operative From Cardiac Surgery |
Resource links provided by NLM:
Further study details as provided by Children's Hospital of Philadelphia:
Primary Outcome Measures:
- PK Profile of Dexmedetomidine [ Time Frame: 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) ] [ Designated as safety issue: No ]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.
| Enrollment: | 56 |
| Study Start Date: | May 2004 |
| Study Completion Date: | October 2006 |
| Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Dosing level
A predetermined dose of Dexmedetomidine
|
Drug: 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.
Other Name: Precedex
|
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.
Eligibility| Ages Eligible for Study: | 1 Month to 24 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Athena Zuppa, Attending Physician, Children's Hospital of Philadelphia |
| ClinicalTrials.gov Identifier: | NCT00573066 History of Changes |
| Other Study ID Numbers: | 2004-5-3770 |
| Study First Received: | December 11, 2007 |
| Results First Received: | March 12, 2010 |
| Last Updated: | February 28, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Children's Hospital of Philadelphia:
|
Postoperative from cardiac surgery Dexmedetomidine |
Additional relevant MeSH terms:
|
Tetralogy of Fallot Hypoplastic Left Heart Syndrome Tricuspid Atresia Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases Congenital Abnormalities Heart Valve Diseases Dexmedetomidine Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013