| ID | Type | Description | Link |
|---|---|---|---|
| CTRC 2006 |
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The purpose of this study is to determine what happens to dexmedetomidine in the body after it has been given to a newborn after heart surgery. We want to learn how long the drug stays in the body, how the drug is metabolized by the body, and how well the medicine works at a particular dose or amount.
This is a single center, dose escalation study of a single bolus dose of dexmedetomidine followed by a continuous infusion for up to 24 hours in neonates who are immediately post-op from cardiac surgery, and require tracheal intubation with mechanical ventilation in the post-op period.
Pediatric populations may benefit from the favorable pharmacodynamic effects of this medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Neonates will be administered a single bolus dose of dexmedetomidine followed by a continuous infusion for up to 24 hours post cardiac surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Dosage Level 1=0.25mcg/kg loading dose, 0.2 mcg/kg/hr infusion Dosage Level 1A= 0.35mcg/kg loading dose, 0.3 mcg/kg/hr infusion Dosage Level 2= 0.5mcg/kg loading dose, 0.4 mcg/kg/hr infusion |
| Measure | Description | Time Frame |
|---|---|---|
| PK Profile of Dexmedetomidine | This study measured the concentration of dex in the body and used those concentrations to determine how quickly the body metabolizes and eliminates dex(concentration-time or pharmacokinetic profile).The concentration of dex in the body is determined through serial blood sampling while administering dex and following discontinuation. | A sparse PK sampling method was utilized. Between 6-12 PK samples were drawn : After start of infusion (0.5, 4-6, 8 hours), immediately prior to end of infusion and following end of infusion (0.25, 0.5, 1, 2-4, 6-8, 10-12 & 18hrs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Felice Su, MD | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
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All subjects were recruited from inpatient cardiac intensive care unit prior to open heart surgery.
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| ID | Title | Description |
|---|---|---|
| FG000 | Neonatal Dose Escalation Cohorts | Neonates will be administered a single bolus dose of dexmedetomidine followed by a continuous infusion for up to 24 hours post cardiac surgery. Cohort 1--0.25 mcg/kg loading dose, 0.2 mcg/kg/hr infusion Cohort 1A--0.35 mcg/kg loading dose, 0.3 mcg/kg/hr infusion Cohort 2--0.5 mcg/kg loading dose, 0.4 mcg/kg/hr infusion |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dosing Cohorts | Neonates will be administered a single bolus dose of dexmedetomidine followed by a continuous infuusion for up to 24 hours post cardiac surgery. Dexmedetomidine : Dosage Level 1=0.25mcg/kg loading dose, 0.2 mcg/kg/hr infusion Dosage Level 1A= 0.35mcg/kg loading dose, 0.3 mcg/kg/hr infusion Dosage Level 2= 0.5mcg/kg loading dose, 0.4 mcg/kg/hr infusion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | PK Profile of Dexmedetomidine | This study measured the concentration of dex in the body and used those concentrations to determine how quickly the body metabolizes and eliminates dex(concentration-time or pharmacokinetic profile).The concentration of dex in the body is determined through serial blood sampling while administering dex and following discontinuation. | Based on an estimated inter-subject variability of 50% for clearance, a sample size of 32 evaluable subjects will be sufficient to detect an 18% difference (alpha 0.05, power 0.9) in the clearance in this population (38 + 18 L/hr) versus that previously reported in the adult population (46 L/hr). | Posted | Least Squares Mean | Standard Error | mL/min | A sparse PK sampling method was utilized. Between 6-12 PK samples were drawn : After start of infusion (0.5, 4-6, 8 hours), immediately prior to end of infusion and following end of infusion (0.25, 0.5, 1, 2-4, 6-8, 10-12 & 18hrs) |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dosing Cohorts | Neonates will be administered a single bolus dose of dexmedetomidine followed by a continuous infuusion for up to 24 hours post cardiac surgery. Dexmedetomidine : Dosage Level 1=0.25mcg/kg loading dose, 0.2 mcg/kg/hr infusion Dosage Level 1A= 0.35mcg/kg loading dose, 0.3 mcg/kg/hr infusion Dosage Level 2= 0.5mcg/kg loading dose, 0.4 mcg/kg/hr infusion |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial ectopy | Cardiac disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| myocardial ischemia | Cardiac disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Athena Zuppa | The Children's Hospital of Philadelphia | 267-426-5753 | zuppa@email.chop.edu |
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| ID | Term |
|---|---|
| D013771 | Tetralogy of Fallot |
| D018636 | Hypoplastic Left Heart Syndrome |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Neonates will be administered a single bolus dose of dexmedetomidine followed by a continuous infuusion for up to 24 hours post cardiac surgery. Cohort 1--0.25mcg/kg loading dose, 0.2mcg/kg/hr infusion Cohort 1A--0.35 mcg/kg loading dose, 0.3 mcg/kg/hr infusion Cohort 2--0.5 mcg/kg loading dose, 0.4 mcg/kg/hr infusion |
|
|
| 2 |
| 30 |
| 3 |
| 30 |
| accelerated junctional rhythm | Cardiac disorders |
|
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| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |