A Phase I Study of Dexmedetomidine Bolus and Infusion in Corrective Infant Cardiac Surgery: Safety and Pharmacokinetics
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ClinicalTrials.gov Identifier: NCT01915277 |
Recruitment Status
:
Completed
First Posted
: August 2, 2013
Last Update Posted
: March 23, 2018
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Transposition of the Great Arteries Tetralogy of Fallot Ventricular Septal Defect | Drug: Dexmedetomidine | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 119 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I Study of Dexmedetomidine Bolus and Infusion in Corrective Infant Cardiac Surgery: Safety and Pharmacokinetics |
Actual Study Start Date : | April 2, 2014 |
Actual Primary Completion Date : | October 16, 2017 |
Actual Study Completion Date : | October 17, 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Neonate dosing cohort 1
Neonate dexmedetomidine dosing cohort 1
|
Drug: Dexmedetomidine
Other Name: Precedex, dexmedetomidine HCl
|
Experimental: Neonate dosing cohort 2
Neonate dexmedetomidine dosing cohort 2
|
Drug: Dexmedetomidine
Other Name: Precedex, dexmedetomidine HCl
|
Experimental: Neonate dosing cohort 3
Neonate dexmedetomidine dosing cohort 3
|
Drug: Dexmedetomidine
Other Name: Precedex, dexmedetomidine HCl
|
Experimental: Neonate dosing cohort 4
Neonate dexmedetomidine dosing cohort 4
|
Drug: Dexmedetomidine
Other Name: Precedex, dexmedetomidine HCl
|
Experimental: Neonate dosing cohort 5
Neonate dexmedetomidine dosing cohort 5
|
Drug: Dexmedetomidine
Other Name: Precedex, dexmedetomidine HCl
|
Experimental: Infant dosing cohort 1
Infant dexmedetomidine dosing cohort 1
|
Drug: Dexmedetomidine
Other Name: Precedex, dexmedetomidine HCl
|
Experimental: Infant dosing cohort 2
Infant dexmedetomidine dosing cohort 2
|
Drug: Dexmedetomidine
Other Name: Precedex, dexmedetomidine HCl
|
Experimental: Infant dosing cohort 3
Infant dexmedetomidine dosing cohort 3
|
Drug: Dexmedetomidine
Other Name: Precedex, dexmedetomidine HCl
|
Experimental: Infant dosing cohort 4
Infant dexmedetomidine dosing cohort 4
|
Drug: Dexmedetomidine
Other Name: Precedex, dexmedetomidine HCl
|
Experimental: Infant dosing cohort 5
Infant dexmedetomidine dosing cohort 5
|
Drug: Dexmedetomidine
Other Name: Precedex, dexmedetomidine HCl
|
- 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.
- 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.

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Ages Eligible for Study: | up to 180 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01915277
United States, Massachusetts | |
Boston Children's Hospital | |
Boston, Massachusetts, United States, 02111 | |
United States, Michigan | |
University of Michigan | |
Ann Arbor, Michigan, United States, 48109 | |
United States, Pennsylvania | |
Childrens Hospital of Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Texas | |
Texas Children's Hospital | |
Houston, Texas, United States, 77030 |
Responsible Party: | New England Research Institutes |
ClinicalTrials.gov Identifier: | NCT01915277 History of Changes |
Other Study ID Numbers: |
PHN-DEX |
First Posted: | August 2, 2013 Key Record Dates |
Last Update Posted: | March 23, 2018 |
Last Verified: | March 2018 |
Keywords provided by New England Research Institutes:
Pediatric corrective cardiac surgery |
Additional relevant MeSH terms:
Heart Septal Defects Tetralogy of Fallot Heart Septal Defects, Ventricular Transposition of Great Vessels Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases Congenital Abnormalities Dexmedetomidine Hypnotics and Sedatives Central Nervous System Depressants |
Physiological Effects of Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |