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NCT00351299 · ClinicalTrials.gov registry record · Phase 2

Randomized Controlled Trial of Dexmedetomidine for the Treatment of Intensive Care Unit (ICU) Delirium

A Phase 2 study, sponsored by Brigham and Women's Hospital.

Completed
Registry status
Phase 2
Development phase
53
Enrollment target

NCT00351299: Completed Phase 2 study, sponsored by Brigham and Women's Hospital.

NCT00351299 is a Phase 2 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 53 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00351299, a Phase 2 study, has completed, sponsored by Brigham and Women's Hospital.

COMPLETED
Registry status
Phase 2
Development phase
53 participants
Enrollment target

Study Summary

The purpose of the research is to see if dexmedetomidine (a drug that has a calming effect - a sedative) is effective for the treatment of acute delirium

Primary Outcome

Resolution of delirium as defined by 2 consecutive negative CAM-ICU assessments. The Confusion Assessment Method for the ICU (CAM-ICU). The CAM-ICU assesses the four features of delirium: feature 1 is an acute change in mental status or a fluctuating mental status, feature 2 is inattention, feature 3 is altered level of consciousness, and feature 4 is disorganized thinking.

Interventions

  • OTHER Standard of Care
  • DRUG Dexmedetomidine

Trial Details

FieldValue
Enrollment Target 53 participants
Start Date 2006-01
Est. Completion 2012-10
Phase Phase 2
Brigham and Women's Hospital

937 total trials

What the finished NCT00351299 record still lists

NCT00351299 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower).

The record links to 0 conditions, and to 2 interventions - of which Standard of Care is the first listed.

NCT00351299 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00351299 about?

NCT00351299 is a clinical study titled "Randomized Controlled Trial of Dexmedetomidine for the Treatment of Intensive Care Unit (ICU) Delirium". The purpose of the research is to see if dexmedetomidine (a drug that has a calming effect - a sedative) is effective for the treatment of acute delirium

What is the current status of trial NCT00351299?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2006-01. Estimated completion is 2012-10.

What interventions are being tested in trial NCT00351299?

The interventions under investigation include: Standard of Care (OTHER), Dexmedetomidine (DRUG).

Who is sponsoring clinical trial NCT00351299?

This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00351299's enrollment target sits among peer trials

53 1171st of 2000 higher than 820 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT00351299, the US trial registry maintained by the National Library of Medicine. NCT00351299 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.