Understanding Dexmedetomidine in Neonates After Open Heart Surgery
This study has been completed.
Sponsor:
Athena Zuppa
Information provided by (Responsible Party):
Athena Zuppa, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00576381
First received: December 17, 2007
Last updated: April 10, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Tetrology of Fallot Heart Ventricle Hypoplastic Left Heart |
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 and Pharmacodynamics of Dexmedetomidine in Neonates Following Open Heart 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: 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) ] [ 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: | 30 |
| Study Start Date: | April 2006 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Neonates will be administered a single bolus dose of dexmedetomidine followed by a continuous infusion for up to 24 hours post cardiac surgery.
|
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
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 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.
Eligibility| Ages Eligible for Study: | up to 30 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00576381
Locations
| United States, Pennsylvania | |
| The Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
Sponsors and Collaborators
Athena Zuppa
Investigators
| Principal Investigator: | Felice Su, MD | Children's Hospital of Philadelphia |
More Information
No publications provided
| Responsible Party: | Athena Zuppa, Principal Investigator, Children's Hospital of Philadelphia |
| ClinicalTrials.gov Identifier: | NCT00576381 History of Changes |
| Obsolete Identifiers: | NCT00516529 |
| Other Study ID Numbers: | 2006-4-4757, CTRC 2006 |
| Study First Received: | December 17, 2007 |
| Results First Received: | December 13, 2012 |
| Last Updated: | April 10, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Children's Hospital of Philadelphia:
|
Precedex Open Heart Surgery Dexmedetomidine Sedation |
Additional relevant MeSH terms:
|
Hypoplastic Left Heart Syndrome Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases Congenital Abnormalities 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