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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 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.

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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).

Conditions Studied

Interventions

  • DRUG Dexmedetomidine
  • DRUG Lorazepam

Study Locations (1)

Tennessee

  • Vanderbilt University Medical Center - Nashville

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2004-08
Est. Completion 2016-12
Phase Phase 2

Sponsor

Vanderbilt University

430 total trials

What the Registry Record Tells You About NCT00095251

The ClinicalTrials.gov registry entry for NCT00095251 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 886-participant average among 62 other Delirium trials with a reported enrollment target (89% lower). The listed sponsor is Vanderbilt University, which has 430 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.