Heart Defects, CongenitalPhase 4DEXLOSNeuroNCT05369949
DEX vs SEVO in Congenital Heart Surgery
A Phase 4 study testing DEX group in people with Heart Defects, Congenital, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Trial summary
Anesthesia-related neurotoxicity in the developing brain is still a concern although evidence in humans is debatable. Moreover, it is unclear whether repeated and/or prolonged exposures are harmless and whether their effects are more pronounced in newborns and infants with brains more vulnerable to injury. Read more about this study
- Who is it for?
- Ages 1 day to 3 years
- Conditions the study is for
- Heart Defects, Congenital
- What is being tested?
- DEX group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 5 Jan 2023to 30 Jun 2026
- Phase
- Phase 4
- 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 1 day to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients up to 3 years
- Must undergo cardiac surgery with CPB
Who cannot join
- Preoperative chronic kidney disease (glomerular filtration rate of less than 30 ml/min per 1.73m2 for greater than 3 months)
- Preoperative cerebral hemorrhage, stroke or
- Preoperative seizures
- Abnormal preoperative cerebral ultrasound
- Preoperative Extracorporeal Life Support
- Preoperative sedated and intubated patients
Show all 9Show fewer
- Preterm newborns (< 32 W gestational age)
- Newborns weighing < 2 kg
- Patients with Williams-Beuren syndrome.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of DEXmedetomidine and LOw Dose Sevoflurane on the Release of Serum Neurofilament Light in Congenital Cardiac Surgery.
Anesthesia-related neurotoxicity in the developing brain is still a concern although evidence in humans is debatable. Moreover, it is unclear whether repeated and/or prolonged exposures are harmless and whether their effects are more pronounced in newborns and infants with brains more vulnerable to injury. One such specific group of patients is children with congenital heart disease (CHD). Nearly, half of the school-age survivors with CHD exhibit neurodevelopmental symptoms. It is thus important to elucidate whether any plausible neurotoxicity of the commonly used anesthetic agents can be observed in this population, and whether specific neuroprotective strategies can be demonstrated within the frame of a randomized controlled trial (RCT).
Animal data have shown that dexmedetomidine (DEX) induces neuroprotective effects only at well-adjusted doses. One major issue with trials of anesthetic neurotoxicity is the latency between the conduct of these studies and the assessment of neurodevelopmental outcome. In contrast, the use of biomarkers of neuronal injury could be extremely valuable. Serum Neurofilament Light (NfL) has been shown to be a sensitive and specific marker of neuronal injury and is associated with neurologic outcome of children with various pathologies. The investigators hypothesize that in congenital heart surgery, use of DEX as main anesthetic agent in conjunction with low dose sevoflurane results in less release of serum NfL and is thus potentially less neurotoxic compared to the current standard of care. The hypothesis is tested with a RCT including patients between 0 - 3y undergoing surgery with cardiopulmonary bypass. To avoid any neurotoxicity due to anesthetic overdose, intraoperative burst suppression will be avoided. In addition to postoperative comparison of serum NfL, postoperative electroencephalogram and neurodevelopmental outcome of both groups will be compared taking into consideration the genetic background.
- Conditions
- Heart Defects, Congenital
- Being tested
- DEX group, Control group
- 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.
DEX groupDrug
Participants will receive a dexmedetomidine infusion in addition to low dose sevoflurane anesthesia.
Control groupOther
Participants will receive general anesthesia based on institutional's practice with commonly used doses of sevoflurane.
| Study group | Role | What they receive |
|---|---|---|
| DEX group | Experimental | Participants will receive an intraoperative and postoperative DEX infusion. In addition a low dose of sevoflurane will be administered. Receives: Drug: DEX group |
| Control group | Active comparator | Participants will receive general anesthesia with sevoflurane according to institutinal's practice. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of serum Neurofilament Light
To show a difference of change in serum NfL concentrations between both groups at 24h compared to baseline values.
Measured: At 24 hours postoperatively
Secondary outcomes (16)
Concentration of serum Neurofilament Light
Measured: Baseline before start of anesthesia
Concentration of serum Neurofilament Light
Measured: Start of cardiopulmonary bypass
Concentration of serum Neurofilament Light
Measured: At 72 hours postoperatively
Concentration of serum Neurofilament Light
Measured: At postoperative day 5
Neurodevelopmental outcome testing
Bailey Scales of Infant and Toddler Development - Third Edition. Higher scores are better.
Measured: 3 months postoperatively
Neurodevelopmental outcome testing
Bailey Scales of Infant and Toddler Development - Third Edition. Higher scores are better.
Measured: 6 months postoperatively
Postoperative electroencephalogram registration
Number of seizures
Measured: 24 hours
Dose of Analgesics
Use and dose of analgesics
Measured: 72 hours postoperatively
Renal function
Defined by pediatric RIFLE criteria
Measured: 7 days postoperatively
Concentration of regional cerebral oxygenation
Area Under Curve of time spent below rSO2 levels of 50%; Area Under Curve of time spent below baseline rSO2 levels
Measured: Intraoperatively
Postoperative electroencephalogram registration
Number of burst-suppression episodes
Measured: 24 hours
Postoperative electroencephalogram registration
Duration of burst-suppression episodes
Measured: 24 hours
Postoperative electroencephalogram registration
Duration of seizures
Measured: 24 hours
Time of exsudation
time to extubation
Measured: 7 days postoperatively
Pediatric Intensive Care Unit stay
Duration of stay in Pediatric Intensive Care Unit
Measured: Up to 24 weeks
Hospital stay
Days of hospital stay
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start5 Jan 2023 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Defects, CongenitalStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The Intervention Drug is DEXMEDETOMIDINE
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Momeni, MD, PhD, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Investigators
- Mona Momeni, MD, PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369949
- Sponsor's protocol ID
- Ethical Advice
- Acronym
- DEXLOSNeuro
- Status last verified
- Jul 2022
- First submitted
- 21 Apr 2022
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of DEXmedetomidine and LOw Dose Sevoflurane on the Release of Serum Neurofilament Light in Congenital Cardiac Surgery.
- ClinicalTrials.gov ID
- NCT05369949
- Acronym / sponsor ID
- DEXLOSNeuro / Ethical Advice
- Conditions
- Heart Defects, Congenital
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 5 Jan 2023 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 11 May 2022 (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.
Anesthesia-related neurotoxicity in the developing brain is still a concern although evidence in humans is debatable. Moreover, it is unclear whether repeated and/or prolonged exposures are harmless and whether their effects are more pronounced in newborns and infants with brains more vulnerable to injury. One such specific group of patients is children with congenital heart disease (CHD). Nearly, half of the school-age survivors with CHD exhibit neurodevelopmental symptoms. It is thus important to elucidate whether any plausible neurotoxicity of the commonly used anesthetic agents can be observed in this population, and whether specific neuroprotective strategies can be demonstrated within the frame of a randomized controlled trial (RCT).
Animal data have shown that dexmedetomidine (DEX) induces neuroprotective effects only at well-adjusted doses. One major issue with trials of anesthetic neurotoxicity is the latency between the conduct of these studies and the assessment of neurodevelopmental outcome. In contrast, the use of biomarkers of neuronal injury could be extremely valuable. Serum Neurofilament Light (NfL) has been shown to be a sensitive and specific marker of neuronal injury and is associated with neurologic outcome of children with various pathologies. The investigators hypothesize that in congenital heart surgery, use of DEX as main anesthetic agent in conjunction with low dose sevoflurane results in less release of serum NfL and is thus potentially less neurotoxic compared to the current standard of care. The hypothesis is tested with a RCT including patients between 0 - 3y undergoing surgery with cardiopulmonary bypass. To avoid any neurotoxicity due to anesthetic overdose, intraoperative burst suppression will be avoided. In addition to postoperative comparison of serum NfL, postoperative electroencephalogram and neurodevelopmental outcome of both groups will be compared taking into consideration the genetic background.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The Intervention Drug is DEXMEDETOMIDINE
| Arm | Type | Receives |
|---|---|---|
| DEX group | Experimental | Drug: DEX groupParticipants will receive an intraoperative and postoperative DEX infusion. In addition a low dose of sevoflurane will be administered. |
| Control group | Active comparator | Other: Control groupParticipants will receive general anesthesia with sevoflurane according to institutinal's practice. |
Who may qualify
- Ages
- 1 day to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients up to 3 years
- Must undergo cardiac surgery with CPB
Key exclusion criteria (9 listed)
- Preoperative chronic kidney disease (glomerular filtration rate of less than 30 ml/min per 1.73m2 for greater than 3 months)
- Preoperative cerebral hemorrhage, stroke or
- Preoperative seizures
- Abnormal preoperative cerebral ultrasound
- Preoperative Extracorporeal Life Support
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 |
|---|---|---|
| DEX groupParticipants will receive a dexmedetomidine infusion in addition to low dose sevoflurane anesthesia. | Drug | DEX group |
| Control groupParticipants will receive general anesthesia based on institutional's practice with commonly used doses of sevoflurane. | Other | Control group |
Primary outcome
Concentration of serum Neurofilament Light
Time frame: At 24 hours postoperatively
To show a difference of change in serum NfL concentrations between both groups at 24h compared to baseline values.
16 secondary outcomes
Concentration of serum Neurofilament Light
Time frame: Baseline before start of anesthesia
Concentration of serum Neurofilament Light
Time frame: Start of cardiopulmonary bypass
Concentration of serum Neurofilament Light
Time frame: At 72 hours postoperatively
Concentration of serum Neurofilament Light
Time frame: At postoperative day 5
Neurodevelopmental outcome testing
Time frame: 3 months postoperatively
Neurodevelopmental outcome testing
Time frame: 6 months postoperatively
Postoperative electroencephalogram registration
Time frame: 24 hours
Dose of Analgesics
Time frame: 72 hours postoperatively
Renal function
Time frame: 7 days postoperatively
Concentration of regional cerebral oxygenation
Time frame: Intraoperatively
Postoperative electroencephalogram registration
Time frame: 24 hours
Postoperative electroencephalogram registration
Time frame: 24 hours
Postoperative electroencephalogram registration
Time frame: 24 hours
Time of exsudation
Time frame: 7 days postoperatively
Pediatric Intensive Care Unit stay
Time frame: Up to 24 weeks
Hospital stay
Time frame: Up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Mona Momeni, MD, PhD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DEX group in people with Heart Defects, Congenital, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
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 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Mona Momeni, MD, PhD (003227647029, mona.momeni@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of serum Neurofilament Light (time frame: At 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2022.