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Completed

NCT Number: NCT01915277

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

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.

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Key information

Conditions

Transposition of the Great Arteries Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Ventricular Tetralogy of Fallot Transposition of Great Vessels Ventricular Septal Defect

Age range

Up to 180 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Boston Children's Hospital, Boston, Massachusetts, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • 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).
  • Enrollment in the PHN Collaborative Learning Study, if tetralogy of Fallot 91-180 days of age only.
  • 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 after 7 days of age, >1.2 mg/dL if <7 days of age, within 72 hours of operation.
  • Preoperative administration of DEX or clonidine within 72 hours of operation.
  • Major congenital anomaly(ies) outside the cardiovascular system that in the investigator's opinion would potentially affect safety or pharmacokinetics.
  • Preoperative central nervous system injury resulting in clinical signs and symptoms: coma, seizures, hemiparesis.
  • 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.
  • 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.
  • History of cardiac arrest or ECMO cannulation.

Treatment and study plan

Dexmedetomidine

Drug

Other names: Precedex, dexmedetomidine HCl

Primary outcomes

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

    Time frame: Within 4 hours after DEX adminstration

    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 outcomes

  1. Plasma concentration of DEX

    Time frame: Intraoperatively and up to 36 hours post-operatively

    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.

Sponsors and collaborators

Lead sponsor

Carelon Research

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Aug 2, 2013
Registry last updated
Mar 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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