Congenital Heart DiseaseNCT04484922
Dexmedetomidine Neuroprotection in Pediatric Cardiac Surgery
A study testing Dexmedetomidine and Normal saline in people with Congenital Heart Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Neurodevelopmental disability is the most significant complication for survivors of infant surgery for congenital heart disease. In this study we sought to determine if intraoperative continuous infusion of dexmedetomidine are associated with neurodevelopmental outcomes at 12 months. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Dexmedetomidine and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Aug 2020to 31 May 2023
- Phase
- Interventional
- 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 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates undergoing cardiac surgery
- Infants undergoing cardiac surgery with cardiopulmonary bypass (atrial septal defect repair, ventricular septal defect repair, or tetralogy of fallot repair)
Who cannot join
- History of hypersensitivity of any drug
- Presence of hypotension or bradycardia considering age Bradycardia (heart rate < 80 beats/min) or hypotension (systolic blood pressure < 70mmHg for infants, < 60mmHg for neonates)
- Elevated liver enzyme levels (aspartate transaminase >100unit/L, alanine aminostrasferase > 50 unit/L)
- surgery with deep hypothermic circulatory arrest
- Presence of complex cardiac defect
- single ventricular physiology
Show all 9Show fewer
- plan of additional operation within a year
- preoperative use of beta-agonists
- presence of history of any neurological disorder
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul national university hospital
Seoul
Eun-hee Kim
About this study
Official title: The Effect of Dexmedetomidine on Neuroprotection in Pediatric Cardiac Surgery Patients: a Randomized Controlled Trial
Neurodevelopmental disability is the most significant complication for survivors of infant surgery for congenital heart disease. In this study we sought to determine if intraoperative continuous infusion of dexmedetomidine are associated with neurodevelopmental outcomes at 12 months.
- Conditions
- Congenital Heart Disease
- Being tested
- Dexmedetomidine, Normal saline
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
continuous infusion of dexmedetomidine during the surgery
Normal salineDrug
continuous infusion of normal saline during the surgery
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | Not described Receives: Drug: Dexmedetomidine |
| Control | Placebo comparator | Not described Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bayley scales of Infant development
Developmental outcomes at each assessment and within each domain (cognitive, language, and motor) were classified as "average" if they were within 1 SD of the mean or higher (scores .85), "at risk" if they were 1 to 2 SD below the mean (scores 70-84), and "delayed" if they were .2SD below the mean (,70). The trajectory of development over time in each domain (cognitive, language, and motor)
Measured: 1 year after the surgery
Secondary outcomes (7)
neurodevelopment biomarker
plasma glial fibrillary acidic protein concentration
Measured: intraoperative (before skin incision, end of hypothermia, end of cardiopulmonary bypass), 4 hours after end of surgery
inflammation
level of IL-6
Measured: 4 hours after end of surgery
acute kidney injury
urinary NGAL
Measured: 2 hours after end of cardiopulmonary bypass
myocardial injury
level of Troponin i
Measured: intraoperative (before skin incision, end of cardiopulmonary bypass), 4 hours after end of surgery, 24 hours after end of surgery
anesthesia monitoring
Bispectral index, end tidal sevoflurane
Measured: intraoperative (from anesthetic induction to end of surgery)
fluid management
amount of transfusion, ROTEM® values
Measured: intraoperative (from anesthetic induction to end of surgery)
fluid management
blood loss
Measured: intraoperative (from anesthetic induction to end of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start25 Aug 2020
- Primary completion31 May 2023 (estimated)
- Study completion31 May 2023 (estimated)
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 Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun-hee Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04484922
- Sponsor's protocol ID
- 2001-062-1095
- Status last verified
- Feb 2022
- First submitted
- 21 Jul 2020
- Last updated
- 2 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ji SH, Kang P, Song IS, Jang YE, Lee JH, Kim JT, Kim HS, Kim EH. The effect of dexmedetomidine on neuroprotection in pediatric cardiac surgery patients: study protocol for a prospective randomized controlled trial. Trials. 2022 Apr 8;23(1):271. doi: 10.1186/s13063-022-06217-9.
PubMed 35395776
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexmedetomidine on Neuroprotection in Pediatric Cardiac Surgery Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04484922
- Acronym / sponsor ID
- 2001-062-1095
- Conditions
- Congenital Heart Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 24 Jul 2020 (actual)
- 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.
Neurodevelopmental disability is the most significant complication for survivors of infant surgery for congenital heart disease. In this study we sought to determine if intraoperative continuous infusion of dexmedetomidine are associated with neurodevelopmental outcomes at 12 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: Dexmedetomidine |
| Control | Placebo comparator | Drug: Normal saline |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Neonates undergoing cardiac surgery
- Infants undergoing cardiac surgery with cardiopulmonary bypass (atrial septal defect repair, ventricular septal defect repair, or tetralogy of fallot repair)
Key exclusion criteria (9 listed)
- History of hypersensitivity of any drug
- Presence of hypotension or bradycardia considering age Bradycardia (heart rate < 80 beats/min) or hypotension (systolic blood pressure < 70mmHg for infants, < 60mmHg for neonates)
- Elevated liver enzyme levels (aspartate transaminase >100unit/L, alanine aminostrasferase > 50 unit/L)
- surgery with deep hypothermic circulatory arrest
- Presence of complex cardiac defect
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 |
|---|---|---|
| Dexmedetomidinecontinuous infusion of dexmedetomidine during the surgery | Drug | Dexmedetomidine |
| Normal salinecontinuous infusion of normal saline during the surgery | Drug | Control |
Primary outcome
Bayley scales of Infant development
Time frame: 1 year after the surgery
Developmental outcomes at each assessment and within each domain (cognitive, language, and motor) were classified as "average" if they were within 1 SD of the mean or higher (scores .85), "at risk" if they were 1 to 2 SD below the mean (scores 70-84), and "delayed" if they were .2SD below the mean (,70). The trajectory of development over time in each domain (cognitive, language, and motor)
7 secondary outcomes
neurodevelopment biomarker
Time frame: intraoperative (before skin incision, end of hypothermia, end of cardiopulmonary bypass), 4 hours after end of surgery
inflammation
Time frame: 4 hours after end of surgery
acute kidney injury
Time frame: 2 hours after end of cardiopulmonary bypass
myocardial injury
Time frame: intraoperative (before skin incision, end of cardiopulmonary bypass), 4 hours after end of surgery, 24 hours after end of surgery
anesthesia monitoring
Time frame: intraoperative (from anesthetic induction to end of surgery)
fluid management
Time frame: intraoperative (from anesthetic induction to end of surgery)
fluid management
Time frame: intraoperative (from anesthetic induction to end of surgery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- Derived from this study: PubMed 35395776Ji SH, Kang P, Song IS, Jang YE, Lee JH, Kim JT, Kim HS, Kim EH. The effect of dexmedetomidine on neuroprotection in pediatric cardiac surgery patients: study protocol for a prospective randomized controlled trial. Trials. 2022 Apr 8;23(1):271. doi: 10.1186/s13063-022-06217-9.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and Normal saline in people with Congenital Heart Disease, run by Seoul National University Hospital at 1 site in South Korea.
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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eun-hee Kim (+82-01-9933-5014, beloveun@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bayley scales of Infant development (time frame: 1 year after the surgery). 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 NCT04484922, 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 2 Feb 2022.