Goal-Directed Sedation in Mechanically Ventilated Infants and Children
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 dy
| Condition(s) | Delirium, Critical Illness, Sedation Complication, Executive Dysfunction, Post Traumatic Stress Disorder |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | 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. The mini-MENDS trial will compare dexmedetomidine and midazolam, and determine the best sedative medication to redu |
| Who can participate | Inclusion 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 3) requiring mechanical ventilation (MV) and sedation. Pre-pubescent children (\<11 years) are typically different from older children who often behave physiologically more similar to adults. Pre-pubescent children are more likely to be admitted to the PICU and are undergoing a steeper curve of neurocognitive maturation. Therefore, these patients may be at greatest risk for worse brain dysfunction. Exclusion Criteria: Patients will be excluded (i.e., not approached for consent) if any one is present: 1. Receiving continuous sedation for \> 72 hours pri |
| Ages | 44 Weeks to 11 Years |
| Sex | All |
| Lead sponsor | Vanderbilt University Medical Center |
| Locations | Nashville, Tennessee, United States |
| Start date | 2021-05-10 |
| NCT ID | NCT04801589 |
| Official listing | https://clinicaltrials.gov/study/NCT04801589 |