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A Phase I Study of Dexmedetomidine Bolus and Infusion in Corrective Infant Cardiac Surgery: Safety and Pharmacokinetics

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by New England Research Institutes
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New England Research Institutes
ClinicalTrials.gov Identifier:
NCT01915277
First received: July 30, 2013
Last updated: April 4, 2014
Last verified: July 2013
  Purpose

The purpose of this Phase I study is to determine the safety of a drug called dexmedetomidine (DEX) as part of a balanced general anesthetic and sedative strategy for neonates and infants undergoing corrective cardiac surgery that requires the use of cardiopulmonary bypass for congenital cardiac problems. This study will also design and validate a dosing schema for the use of DEX as described above.


Condition Intervention Phase
Transposition of the Great Arteries
Tetralogy of Fallot
Ventricular Septal Defect
Drug: Dexmedetomidine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Dexmedetomidine Bolus and Infusion in Corrective Infant Cardiac Surgery: Safety and Pharmacokinetics

Resource links provided by NLM:


Further study details as provided by New England Research Institutes:

Primary Outcome Measures:
  • The occurrence of a safety event that is possibly, probably or definitely related to DEX administration [ Time Frame: Within 4 hours after DEX adminstration ] [ Designated as safety issue: Yes ]

    The occurrence of any of the following that is possibly, probably, or definitely related to DEX administration:

    • Bradycardia
    • Heart block
    • Junctional rhythm
    • Hypotension
    • Excessive sedation
    • Cardiac arrest or ECMO cannulation
    • Serious Adverse Event (SAE)

    Both the DEX dose, and DEX exposure will be assessed for associations with the primary outcome.



Secondary Outcome Measures:
  • Plasma concentration of DEX [ Time Frame: Intraoperatively and up to 36 hours post-operatively ] [ Designated as safety issue: No ]
    Plasma concentrations of dex obtained intraoperatively and up to 36 hours post-operatively will be used to create drug dosing models. These models will then be evaluated to determine how effective they are at achieving targeted plasma concentration levels.


Estimated Enrollment: 106
Study Start Date: March 2014
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Neonate dosing cohort 1
Neonate dexmedetomidine dosing cohort 1
Drug: Dexmedetomidine
Other Name: Precedex, dexmedetomidine HCl
Experimental: Neonate dosing cohort 2
Neonate dexmedetomidine dosing cohort 2
Drug: Dexmedetomidine
Other Name: Precedex, dexmedetomidine HCl
Experimental: Neonate dosing cohort 3
Neonate dexmedetomidine dosing cohort 3
Drug: Dexmedetomidine
Other Name: Precedex, dexmedetomidine HCl
Experimental: Neonate dosing cohort 4
Neonate dexmedetomidine dosing cohort 4
Drug: Dexmedetomidine
Other Name: Precedex, dexmedetomidine HCl
Experimental: Neonate dosing cohort 5
Neonate dexmedetomidine dosing cohort 5
Drug: Dexmedetomidine
Other Name: Precedex, dexmedetomidine HCl
Experimental: Infant dosing cohort 1
Infant dexmedetomidine dosing cohort 1
Drug: Dexmedetomidine
Other Name: Precedex, dexmedetomidine HCl
Experimental: Infant dosing cohort 2
Infant dexmedetomidine dosing cohort 2
Drug: Dexmedetomidine
Other Name: Precedex, dexmedetomidine HCl
Experimental: Infant dosing cohort 3
Infant dexmedetomidine dosing cohort 3
Drug: Dexmedetomidine
Other Name: Precedex, dexmedetomidine HCl
Experimental: Infant dosing cohort 4
Infant dexmedetomidine dosing cohort 4
Drug: Dexmedetomidine
Other Name: Precedex, dexmedetomidine HCl
Experimental: Infant dosing cohort 5
Infant dexmedetomidine dosing cohort 5
Drug: Dexmedetomidine
Other Name: Precedex, dexmedetomidine HCl

  Eligibility

Ages Eligible for Study:   up to 90 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, age 0 to 90 days.
  • Diagnosis of: D-transposition of the great arteries (with or without ventricular septal defect), or tetralogy of Fallot, or ventricular septal defect (with or without associated atrial septal defect and/or patent ductus arteriosus)
  • Scheduled for complete corrective two-ventricle surgical repair with cardiopulmonary bypass.

Exclusion Criteria:

  • Less than 37 completed weeks' gestational age at birth.
  • Known or suspected hepatic dysfunction; AST and ALT >3X upper limit of normal at the time of screening within 72 hours of operation.
  • Known or suspected renal dysfunction; serum creatinine > 0.8 mg/dL within 72 hours of operation.
  • Preoperative administration of DEX or clonidine within 72 hours of operation.
  • Major congenital anomaly(ies) outside the cardiovascular system.
  • Preoperative central nervous system injury resulting in clinical signs and symptoms: coma, seizures, hemiparesis.
  • Planned period of deep hypothermic circulatory arrest.
  • History of second or third degree heart block.
  • Sinus or junctional bradycardia below 80 BPM sustained for greater than 15 minutes within 72 hours of operation.
  • Junctional rhythm sustained for greater than 15 minutes within 72 hours of operation.
  • Hypotension defined as mean arterial blood pressure below 35 mm Hg for 0-21 day old neonatal patients, and below 40 mm Hg for 22- 90 day old infant patients sustained for greater than 15 minutes within 72 hours of operation.
  • History of cardiac arrest or ECMO cannulation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01915277

Locations
United States, Texas
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Dean B Andropoulos, MD    832-826-5822    dbandrop@texaschildrens.org   
Principal Investigator: Dean B Andropoulos, MD         
Sponsors and Collaborators
New England Research Institutes
  More Information

No publications provided

Responsible Party: New England Research Institutes
ClinicalTrials.gov Identifier: NCT01915277     History of Changes
Other Study ID Numbers: PHN-DEX
Study First Received: July 30, 2013
Last Updated: April 4, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by New England Research Institutes:
Pediatric corrective cardiac surgery

Additional relevant MeSH terms:
Heart Septal Defects
Heart Septal Defects, Ventricular
Heart Defects, Congenital
Tetralogy of Fallot
Transposition of Great Vessels
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Heart Diseases
Dexmedetomidine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics
Analgesics, Non-Narcotic
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014