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NCT00095251 · ClinicalTrials.gov registry record · Phase 2
MENDS Study: Trial in Ventilated ICU Patients Comparing an Alpha2 Agonist Versus a Gamma Aminobutyric Acid (GABA)-Agonist to Determine Delirium Rates, Efficacy of Sedation, Analgesia and Discharge Cognitive Status
A Phase 2 study of Delirium, sponsored by Vanderbilt University.
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT00095251: Completed Phase 2 study of Delirium, sponsored by Vanderbilt University.
NCT00095251 is a Phase 2 study of Delirium that has completed, run by Vanderbilt University. The registered enrollment target is 100 participants, below the 886-participant average among 62 other Delirium trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00095251, a Phase 2 study of Delirium, has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
Delirium has recently been shown as a predictor of death, increased cost, and longer length of stay in ventilated patients. Sedative and analgesic medications relieve anxiety and pain, but may contribute to patients' transitioning into delirium. It is possible that modifying the paradigm for sedation using novel therapies targeted at different receptors, such as dexmedetomidine targeting alpha2 receptors and sparing the GABA receptors, could provide efficacious sedation yet reduce the development, duration, and severity of acute brain dysfunction (delirium).
Primary Outcome
The patients' managing team will set the "goal" or "target" as medically indicated using the RASS 37. A trained research nurse or physician blinded to patients' group assignment and medical management will perform measurement of the "actual" RASS level every 12 hours. Comparisons will be made between the actual and target RASS levels to determine the primary outcome measure, which is the accuracy of achieving the target sedation level.
Conditions Studied
Interventions
- DRUG Dexmedetomidine
- DRUG Lorazepam
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2004-08 |
| Est. Completion | 2016-12 |
| Phase | Phase 2 |
What the finished NCT00095251 record still lists
NCT00095251 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 886-participant average among 62 other Delirium trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Delirium appearing as the primary indexed condition, and to 2 interventions - of which Dexmedetomidine is the first listed.
NCT00095251 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT00095251 about?
NCT00095251 is a clinical study titled "MENDS Study: Trial in Ventilated ICU Patients Comparing an Alpha2 Agonist Versus a Gamma Aminobutyric Acid (GABA)-Agonist to Determine Delirium Rates, Efficacy of Sedation, Analgesia and Discharge Cognitive Status". Delirium has recently been shown as a predictor of death, increased cost, and longer length of stay in ventilated patients. Sedative and analgesic medications relieve anxiety and pain, but may contribute to patients' transitioning into delirium. It is possible that modifying the paradigm for sedatio...
What is the current status of trial NCT00095251?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2004-08. Estimated completion is 2016-12.
What conditions does trial NCT00095251 study?
This clinical trial studies the following conditions: Delirium.
What interventions are being tested in trial NCT00095251?
The interventions under investigation include: Dexmedetomidine (DRUG), Lorazepam (DRUG).
Who is sponsoring clinical trial NCT00095251?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00095251 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
Similar trials for Delirium
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 NCT00095251's enrollment target sits among peer trials
100 38th of 62 higher than 21 of 62 other Delirium trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Delirium 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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