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

NCT ID: NCT01915277

Last Updated: 2018-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-02
• Study Completion Date: 2017-10-17

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.

Conditions

Transposition of the Great Arteries; Tetralogy of Fallot; Ventricular Septal Defect

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neonate dosing cohort 1

Neonate dexmedetomidine dosing cohort 1

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

Neonate dosing cohort 2

Neonate dexmedetomidine dosing cohort 2

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

Neonate dosing cohort 3

Neonate dexmedetomidine dosing cohort 3

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

Neonate dosing cohort 4

Neonate dexmedetomidine dosing cohort 4

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

Neonate dosing cohort 5

Neonate dexmedetomidine dosing cohort 5

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

Infant dosing cohort 1

Infant dexmedetomidine dosing cohort 1

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

Infant dosing cohort 2

Infant dexmedetomidine dosing cohort 2

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

Infant dosing cohort 3

Infant dexmedetomidine dosing cohort 3

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

Infant dosing cohort 4

Infant dexmedetomidine dosing cohort 4

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

Infant dosing cohort 5

Infant dexmedetomidine dosing cohort 5

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

Interventions

Dexmedetomidine

Intervention Type: DRUG

Other Intervention Names

Precedex, dexmedetomidine HCl

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.

• Maximum Eligible Age: 180 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Carelon Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Boston Children's Hospital

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Texas Children's Hospital

Houston, Texas, United States

Countries

United States

References

Zuppa AF, Nicolson SC, Wilder NS, Ibla JC, Gottlieb EA, Burns KM, Stylianou M, Trachtenberg F, Ni H, Skeen TH, Andropoulos DB; Pediatric Heart Network Investigators. Results of a phase 1 multicentre investigation of dexmedetomidine bolus and infusion in corrective infant cardiac surgery. Br J Anaesth. 2019 Dec;123(6):839-852. doi: 10.1016/j.bja.2019.06.026. Epub 2019 Oct 14.

Reference Type: DERIVED

PMID: 31623840 (View on PubMed)

Other Identifiers

PHN-DEX

Identifier Type: -

Identifier Source: org_study_id