A Phase I Study of Dexmedetomidine Bolus and Infusion in Corrective Infant Cardiac Surgery: Safety and Pharmacokinetics
This study is currently recruiting participants.
(see Contacts and Locations)
Verified August 2016 by New England Research Institutes
Sponsor:
New England Research Institutes
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
New England Research Institutes
ClinicalTrials.gov Identifier:
NCT01915277
First received: July 30, 2013
Last updated: August 22, 2016
Last verified: August 2016
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Transposition of the Great Arteries Tetralogy of Fallot Ventricular Septal Defect |
Drug: Dexmedetomidine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study of Dexmedetomidine Bolus and Infusion in Corrective Infant Cardiac Surgery: Safety and Pharmacokinetics |
Resource links provided by NLM:
MedlinePlus related topics:
Heart Surgery
Genetic and Rare Diseases Information Center resources:
Tetralogy of Fallot
Ventricular Septal Defects
Transposition of the Great Arteries
U.S. FDA Resources
Further study details as provided by New England Research Institutes:
Primary Outcome Measures:
- The occurrence of a safety event that is possibly, probably or definitely related to DEX administration [ Time Frame: Within 4 hours after DEX adminstration ] [ Designated as safety issue: Yes ]
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 Outcome Measures:
- Plasma concentration of DEX [ Time Frame: Intraoperatively and up to 36 hours post-operatively ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 106 |
| Study Start Date: | March 2014 |
| Estimated Study Completion Date: | July 2017 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | up to 180 Days (Child) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01915277
Please refer to this study by its ClinicalTrials.gov identifier: NCT01915277
Contacts
| Contact: Julie Miller, MPH, PMP | 617-972-3197 | jmiller@neriscience.com | |
| Contact: Theresa Le | tle@neriscience.com |
Locations
| United States, Massachusetts | |
| Boston Children's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02111 | |
| Contact phnmailbox@neriscience.com | |
| United States, Michigan | |
| University of Michigan | Recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Contact: Nicole Wilder, MD 734-763-2435 nicowild@umich.edu | |
| United States, Pennsylvania | |
| Childrens Hospital of Philadelphia | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Susan Nicholson, MD 215-590-1874 nicholson@email.chop.edu | |
| United States, Texas | |
| Texas Children's Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Dean B Andropoulos, MD 832-826-5822 dbandrop@texaschildrens.org | |
| Principal Investigator: Dean B Andropoulos, MD | |
Sponsors and Collaborators
New England Research Institutes
National Heart, Lung, and Blood Institute (NHLBI)
More Information
| Responsible Party: | New England Research Institutes |
| ClinicalTrials.gov Identifier: | NCT01915277 History of Changes |
| Other Study ID Numbers: | PHN-DEX |
| Study First Received: | July 30, 2013 |
| Last Updated: | August 22, 2016 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by New England Research Institutes:
|
Pediatric corrective cardiac surgery |
Additional relevant MeSH terms:
|
Heart Septal Defects Heart Septal Defects, Ventricular Heart Defects, Congenital Heart Diseases Tetralogy of Fallot Transposition of Great Vessels Cardiovascular Abnormalities Cardiovascular 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 |
ClinicalTrials.gov processed this record on September 23, 2016