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

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Brief Title

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

Official Title

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

Brief Summary

      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.
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

The occurrence of a safety event that is possibly, probably or definitely related to DEX administration

Secondary Outcome

 Plasma concentration of DEX

Condition

Transposition of the Great Arteries

Intervention

Dexmedetomidine

Study Arms / Comparison Groups

 Neonate dosing cohort 1
Description:  Neonate dexmedetomidine dosing cohort 1

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

119

Start Date

April 2, 2014

Completion Date

October 17, 2017

Primary Completion Date

October 16, 2017

Eligibility Criteria

        Inclusion Criteria:

          1. Male or female, age 0 to 180 days at the time of surgery.

          2. 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)

          3. Scheduled for complete corrective two-ventricle surgical repair with cardiopulmonary
             bypass.

        Exclusion Criteria:

          -  1. Less than 37 completed weeks' gestational age at birth for the Neonatal age group
             (0-21 days); less than 36 completed weeks' gestational age at birth for the Infant age
             group (22-180 days).

             2. Enrollment in the PHN Collaborative Learning Study, if tetralogy of Fallot 91-180
             days of age only.

             3. Known or suspected hepatic dysfunction; AST and ALT >3X upper limit of normal at
             the time of screening within 72 hours of operation.

             4. Known or suspected renal dysfunction; serum creatinine > 0.8 mg/dL after 7 days of
             age, >1.2 mg/dL if <7 days of age, within 72 hours of operation.

             5. Preoperative administration of DEX or clonidine within 72 hours of operation.

             6. Major congenital anomaly(ies) outside the cardiovascular system that in the
             investigator's opinion would potentially affect safety or pharmacokinetics.

             7. Preoperative central nervous system injury resulting in clinical signs and
             symptoms: coma, seizures, hemiparesis.

             8. Planned period of deep hypothermic circulatory arrest. 9. History of second or
             third degree heart block. 10. Sinus or junctional bradycardia below 80 BPM sustained
             for greater than 15 minutes within 72 hours of operation. 11. Junctional rhythm
             sustained for greater than 15 minutes within 72 hours of operation.

             12. Hypotension defined as mean arterial blood pressure below 35 mm Hg for 0-21 day
             old neonatal patients, and below 40 mm Hg for 22-180 day old infant patients sustained
             for greater than 15 minutes within 72 hours of operation.

             13. History of cardiac arrest or ECMO cannulation.
      

Gender

All

Ages

N/A - 180 Days

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01915277

Organization ID

PHN-DEX


Responsible Party

Sponsor

Study Sponsor

HealthCore-NERI

Collaborators

 National Heart, Lung, and Blood Institute (NHLBI)

Study Sponsor

, , 


Verification Date

March 2018