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NCT04801589 · ClinicalTrials.gov registry record · Phase 3
Goal-Directed Sedation in Mechanically Ventilated Infants and Children
A Phase 3 study of Post Traumatic Stress Disorder and Critical Illness, sponsored by Vanderbilt University Medical Center.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 372
- Enrollment target
- 1
- Study location
NCT04801589: Recruiting Phase 3 study of Post Traumatic Stress Disorder and Critical Illness, sponsored by Vanderbilt University Medical Center.
NCT04801589 is a Phase 3 study of Post Traumatic Stress Disorder and Critical Illness that is actively recruiting participants, run by Vanderbilt University Medical Center. The registered enrollment target is 372 participants, below the 662-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (44% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04801589, a Phase 3 study of Post Traumatic Stress Disorder and Critical Illness, is actively recruiting participants, sponsored by Vanderbilt University Medical Center.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 372 participants
- Enrollment target
- 1
- Study location
Study 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 reduce delirium and improve duration of ventilation, and functional, psychiatric, and cognitive recovery in our most vulnerable patients-survivors of pediatric critical illness.
Primary Outcome
The analysis of delirium prevalence will be conducted using a modified Intention-to-Treat (ITT) population, defined as all patients who were randomized and received study drug. The investigators chose a 14 day evaluation period for delirium, because it represents the best balance of gaining valuable clinical information, while maximizing resource utilization, given the average study drug infusion to be 5 days and maximum duration to be 10 days. Thus our follow-up period will cover 9 additional d
Conditions Studied
Interventions
- DRUG Midazolam
- DRUG Dexmedetomidine
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 372 participants |
| Start Date | 2021-05-10 |
| Est. Completion | 2026-09-16 |
| Phase | Phase 3 |
What NCT04801589 shows while recruiting
NCT04801589 is an interventional study that assigns participants to a tested intervention. The registered 372 participants enrollment target is mid-sized for trials with a published cap, below the 662-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (44% lower).
The record links to 5 conditions, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 2 interventions - of which Midazolam is the first listed.
NCT04801589 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT04801589 about?
NCT04801589 is a clinical study titled "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...
What is the current status of trial NCT04801589?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 372 participants. The study started on 2021-05-10. Estimated completion is 2026-09-16.
What conditions does trial NCT04801589 study?
This clinical trial studies the following conditions: Post Traumatic Stress Disorder, Critical Illness, Delirium, Executive Dysfunction, Sedation Complication.
What interventions are being tested in trial NCT04801589?
The interventions under investigation include: Midazolam (DRUG), Dexmedetomidine (DRUG).
Who is sponsoring clinical trial NCT04801589?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04801589 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04801589's enrollment target sits among peer trials
372 20th of 262 higher than 243 of 262 other Post Traumatic Stress Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Post Traumatic Stress Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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