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New treatment option for Delirium
Official title Goal-Directed Sedation in Mechanically Ventilated Infants and Children
ClinicalTrials.gov ID: NCT04801589
What this study is testing
What is Dexmedetomidine?
Dexmedetomidine is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for delirium.
Also referred to as Precedex, Dexdor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Ventilated pediatric patients are frequently over-sedated and the majority suffer from delirium, a form of acute brain dysfunction that is an independent predictor of increased risk of dying, length of stay, and costs. Universally prescribed sedative medications-the GABA-ergic benzodiazepines-worsen this brain organ dysfunction and independently prolong duration of ventilation and ICU stay, and the available alternative sedation regimen using dexmedetomidine, an alpha-2 agonist, has been shown to be superior to benzodiazepines in adults, and may mechanistically impact outcomes through positive effects on innate immunity, bacterial clearance, apoptosis, cognition and delirium.
- Phase 3: a large, late-stage study
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 44 to 11
You may be able to join if
- Patients will be eligible for enrollment if they are 1) aged 44 weeks post-menstrual age and up to 11 years, 2) planned admission to the pediatric...
You likely can't join if
- Patients will be excluded (i.e., not approached for consent) if any one is present:
- Receiving continuous sedation for \> 72 hours prior to screening.
- Rapidly resolving respiratory failure at screening, with planned immediate liberation from MV.
- Severe developmental delay at baseline defined as a score of ≥ 4 (severe disability) on the Pediatric Cerebral Performance Category (PCPC) Scale...
- Clinically significant 2nd or 3rd degree heart block or bradycardia \< 60 beats per minute.
- Benzodiazepine dependency with ongoing medical requirement of continuous benzodiazepine (infusion).
See the full eligibility criteria
- Patients will be eligible for enrollment if they are 1) aged 44 weeks post-menstrual age and up to 11 years, 2) planned admission to the pediatric ICU at Monroe Carell Jr. Children's Hospital at Vanderbilt (MCJCHV), and...
- Patients will be excluded (i.e., not approached for consent) if any one is present:
- Receiving continuous sedation for \> 72 hours prior to screening.
- Rapidly resolving respiratory failure at screening, with planned immediate liberation from MV.
- Severe developmental delay at baseline defined as a score of ≥ 4 (severe disability) on the Pediatric Cerebral Performance Category (PCPC) Scale, referencing cognitive status prior to critical illness.
- Clinically significant 2nd or 3rd degree heart block or bradycardia \< 60 beats per minute.
- Benzodiazepine dependency with ongoing medical requirement of continuous benzodiazepine (infusion).
- Inability to co-enroll with another study.
- Expected death or care plan for withdrawal of support measures within 24 hours of enrollment.
- Bilateral vision loss.
- Deafness that will preclude delirium evaluation.
- Inability to understand English that will preclude delirium evaluation. The inability to understand English in verbal participants will not result in exclusion when the research staff is proficient and/or translation...
- Documented allergy to either dexmedetomidine or midazolam.
- Medical requirement of continuous (infusion) neuromuscular blockade administration that is planned ongoing for at least 48 hours at time of screening.
- Inability to start the informed consent process within the 72 hours from the time that all inclusion criteria were met (possible reasons):
- Attending physician refusal
- 72-hour period of eligibility was exceeded before the patient was enrolled
- Legal Authorized Decision Maker (e.g. legal guardian/power of attorney) refusal
- Legal Authorized Decision Maker (e.g. legal guardian/power of attorney) unavailable
- Legal Authorized Decision Maker (e.g. legal guardian/power of attorney) is non-English speaking and available research staff is not proficient and/or translation services are not available in that particular language.
- Adjusted dosing weight is \> 50 kg at time of screening.
The study team makes the final eligibility decision.
Where it's taking place
- Nashville, Tennessee, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 44 weeks to 11 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.