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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01915277
• Date of registration: 30/07/2013
• Prospective Registration: Yes
• Primary sponsor: HealthCore-NERI
• Public title: A Phase I Study of Dexmedetomidine Bolus and Infusion in Corrective Infant Cardiac Surgery: Safety and Pharmacokinetics
• Scientific title: A Phase I Study of Dexmedetomidine Bolus and Infusion in Corrective Infant Cardiac Surgery: Safety and Pharmacokinetics
• Date of first enrolment: April 2, 2014
• Target sample size: 119
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01915277
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Key inclusion & exclusion 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.



Age minimum: N/A
Age maximum: 180 Days
Gender: All

Health Condition(s) or Problem(s) studied

Transposition of the Great Arteries

Tetralogy of Fallot

Ventricular Septal Defect

Intervention(s)

Drug: Dexmedetomidine

Primary Outcome(s)

The occurrence of a safety event that is possibly, probably or definitely related to DEX administration [Time Frame: Within 4 hours after DEX adminstration]

Secondary Outcome(s)

Plasma concentration of DEX [Time Frame: Intraoperatively and up to 36 hours post-operatively]

Secondary ID(s)

PHN-DEX

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Heart, Lung, and Blood Institute (NHLBI)