NCT01915277

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2014

Typical duration for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 2, 2013

Completed
8 months until next milestone

Study Start

First participant enrolled

April 2, 2014

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2017

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2017

Completed
Last Updated

March 23, 2018

Status Verified

March 1, 2018

Enrollment Period

3.5 years

First QC Date

July 30, 2013

Last Update Submit

March 21, 2018

Conditions

Transposition of the Great ArteriesTetralogy of FallotVentricular Septal Defect

Keywords

Pediatric corrective cardiac surgery

Outcome Measures

Primary Outcomes (1)

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

    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.

    Within 4 hours after DEX adminstration

Secondary Outcomes (1)

  • Plasma concentration of DEX

    Intraoperatively and up to 36 hours post-operatively

Study Arms (10)

Neonate dosing cohort 1

EXPERIMENTAL

Neonate dexmedetomidine dosing cohort 1

Drug: Dexmedetomidine

Neonate dosing cohort 2

EXPERIMENTAL

Neonate dexmedetomidine dosing cohort 2

Drug: Dexmedetomidine

Neonate dosing cohort 3

EXPERIMENTAL

Neonate dexmedetomidine dosing cohort 3

Drug: Dexmedetomidine

Neonate dosing cohort 4

EXPERIMENTAL

Neonate dexmedetomidine dosing cohort 4

Drug: Dexmedetomidine

Neonate dosing cohort 5

EXPERIMENTAL

Neonate dexmedetomidine dosing cohort 5

Drug: Dexmedetomidine

Infant dosing cohort 1

EXPERIMENTAL

Infant dexmedetomidine dosing cohort 1

Drug: Dexmedetomidine

Infant dosing cohort 2

EXPERIMENTAL

Infant dexmedetomidine dosing cohort 2

Drug: Dexmedetomidine

Infant dosing cohort 3

EXPERIMENTAL

Infant dexmedetomidine dosing cohort 3

Drug: Dexmedetomidine

Infant dosing cohort 4

EXPERIMENTAL

Infant dexmedetomidine dosing cohort 4

Drug: Dexmedetomidine

Infant dosing cohort 5

EXPERIMENTAL

Infant dexmedetomidine dosing cohort 5

Drug: Dexmedetomidine

Interventions

DexmedetomidineDRUG
Also known as: Precedex, dexmedetomidine HCl
Infant dosing cohort 1Infant dosing cohort 2Infant dosing cohort 3Infant dosing cohort 4Infant dosing cohort 5Neonate dosing cohort 1Neonate dosing cohort 2Neonate dosing cohort 3Neonate dosing cohort 4Neonate dosing cohort 5

Eligibility Criteria

AgeUp to 180 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Boston Children's Hospital

Boston, Massachusetts, 02111, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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.

    PMID: 31623840DERIVED

MeSH Terms

Conditions

Transposition of Great VesselsTetralogy of FallotHeart Septal Defects, Ventricular

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHeart Septal Defects

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2013

First Posted

August 2, 2013

Study Start

April 2, 2014

Primary Completion

October 16, 2017

Study Completion

October 17, 2017

Last Updated

March 23, 2018

Record last verified: 2018-03

Locations

US(4)