Transposition of the Great ArteriesPhase 1NCT01915277
A Phase I Study of Dexmedetomidine Bolus and Infusion in Corrective Infant Cardiac Surgery: Safety and Pharmacokinetics
A Phase 1 study testing Dexmedetomidine in people with Transposition of the Great Arteries and Tetralogy of Fallot, run by Carelon Research at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 180 days
- Conditions the study is for
- Transposition of the Great Arteries, Tetralogy of Fallot, Ventricular Septal Defect
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 4 sitesUnited States
- Study dates
- 2 Apr 2014to 17 Oct 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 180 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Michigan
Ann Arbor, Michigan, 48109
Boston Children's Hospital
Boston, Massachusetts, 02111
Texas Children's Hospital
Houston, Texas, 77030
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
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.
- Being tested
- Dexmedetomidine
- Keywords
- Pediatric corrective cardiac surgery
- Medical subject headings
- Transposition of Great Vessels, Tetralogy of Fallot, Heart Septal Defects, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex, dexmedetomidine HCl
| Study group | Role | What they receive |
|---|---|---|
| Neonate dosing cohort 1 | Experimental | Neonate dexmedetomidine dosing cohort 1 Receives: Drug: Dexmedetomidine |
| Neonate dosing cohort 2 | Experimental | Neonate dexmedetomidine dosing cohort 2 Receives: Drug: Dexmedetomidine |
| Neonate dosing cohort 3 | Experimental | Neonate dexmedetomidine dosing cohort 3 Receives: Drug: Dexmedetomidine |
| Neonate dosing cohort 4 | Experimental | Neonate dexmedetomidine dosing cohort 4 Receives: Drug: Dexmedetomidine |
| Neonate dosing cohort 5 | Experimental | Neonate dexmedetomidine dosing cohort 5 Receives: Drug: Dexmedetomidine |
| Infant dosing cohort 1 | Experimental | Infant dexmedetomidine dosing cohort 1 Receives: Drug: Dexmedetomidine |
| Infant dosing cohort 2 | Experimental | Infant dexmedetomidine dosing cohort 2 Receives: Drug: Dexmedetomidine |
| Infant dosing cohort 3 | Experimental | Infant dexmedetomidine dosing cohort 3 Receives: Drug: Dexmedetomidine |
| Infant dosing cohort 4 | Experimental | Infant dexmedetomidine dosing cohort 4 Receives: Drug: Dexmedetomidine |
| Infant dosing cohort 5 | Experimental | Infant dexmedetomidine dosing cohort 5 Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 4 hours after DEX adminstration
Secondary outcomes (1)
Plasma concentration of DEX
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.
Measured: Intraoperatively and up to 36 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study start2 Apr 2014
- Primary completion16 Oct 2017
- Study completion17 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transposition of the Great ArteriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carelon Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01915277
- Sponsor's protocol ID
- PHN-DEX
- Status last verified
- Mar 2018
- First submitted
- 30 Jul 2013
- Last updated
- 23 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31623840
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Dexmedetomidine Bolus and Infusion in Corrective Infant Cardiac Surgery: Safety and Pharmacokinetics
- ClinicalTrials.gov ID
- NCT01915277
- Acronym / sponsor ID
- PHN-DEX
- Keywords
- Pediatric corrective cardiac surgery
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Carelon ResearchUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 2 Apr 2014 (actual)
- Primary completion
- 16 Oct 2017 (actual)
- Study completion
- 17 Oct 2017 (actual)
- First posted
- 2 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Neonate dosing cohort 1 | Experimental | Drug: DexmedetomidineNeonate dexmedetomidine dosing cohort 1 |
| Neonate dosing cohort 2 | Experimental | Drug: DexmedetomidineNeonate dexmedetomidine dosing cohort 2 |
| Neonate dosing cohort 3 | Experimental | Drug: DexmedetomidineNeonate dexmedetomidine dosing cohort 3 |
| Neonate dosing cohort 4 | Experimental | Drug: DexmedetomidineNeonate dexmedetomidine dosing cohort 4 |
| Neonate dosing cohort 5 | Experimental | Drug: DexmedetomidineNeonate dexmedetomidine dosing cohort 5 |
| Infant dosing cohort 1 | Experimental | Drug: DexmedetomidineInfant dexmedetomidine dosing cohort 1 |
| Infant dosing cohort 2 | Experimental | Drug: DexmedetomidineInfant dexmedetomidine dosing cohort 2 |
| Infant dosing cohort 3 | Experimental | Drug: DexmedetomidineInfant dexmedetomidine dosing cohort 3 |
| Infant dosing cohort 4 | Experimental | Drug: DexmedetomidineInfant dexmedetomidine dosing cohort 4 |
| Infant dosing cohort 5 | Experimental | Drug: DexmedetomidineInfant dexmedetomidine dosing cohort 5 |
Who may qualify
- Ages
- Up to 180 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: Precedex, dexmedetomidine HCl | Drug | Infant dosing cohort 1, Infant dosing cohort 2, Infant dosing cohort 3, Infant dosing cohort 4, Infant dosing cohort 5, Neonate dosing cohort 1, Neonate dosing cohort 2, Neonate dosing cohort 3, Neonate dosing cohort 4, Neonate dosing cohort 5 |
Primary outcome
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.
1 secondary outcome
Plasma concentration of DEX
Time frame: Intraoperatively and up to 36 hours post-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2018.
- Derived from this study: PubMed 31623840Zuppa 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dexmedetomidine in people with Transposition of the Great Arteries and Tetralogy of Fallot, run by Carelon Research at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of a safety event that is possibly, probably or definitely related to DEX administration (time frame: Within 4 hours after DEX adminstration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01915277, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2018.