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NCT01791296 · ClinicalTrials.gov registry record · Phase 4
Does Nightly Dexmedetomidine Improve Sleep and Reduce Delirium in ICU Patients?
A Phase 4 study of Delirium and Sleep Deprivation, sponsored by Maisonneuve-Rosemont Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
- 2
- Study locations
NCT01791296: Completed Phase 4 study of Delirium and Sleep Deprivation, sponsored by Maisonneuve-Rosemont Hospital.
NCT01791296 is a Phase 4 study of Delirium and Sleep Deprivation that has completed, run by Maisonneuve-Rosemont Hospital. 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 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01791296, a Phase 4 study of Delirium and Sleep Deprivation, has completed, sponsored by Maisonneuve-Rosemont Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
- 2
- Study locations
Study Summary
Specific Aims 1. Establish the feasibility of larger trial by implementing a sleep protocol in the ICU at 2 different sites. Specifically will be estimating the recruitment rates of patients and the compliance with both interventions. 2. Measure the safety and tolerance of adding night-time sedation with dexmedetomidine using adverse effects and withdrawal rates as indicators. 3. Measure the effect of nocturnal dexmedetomidine on pertinent clinical outcomes and use this outcome data to plan a larger, multicenter trial in this area. The goal of this study is to determine whether a night-time protocol that incorporates a pharmacologic intervention associated with improved sleep (i.e. dexmedetomidine) will improve sleep quality and reduce the incidence of delirium and sub-syndromal delirium in critically ill patients.
Primary Outcome
Delirium will be assessed with the ICDSC (Intensive Care Delirium Screening CHecklist) q12h \[Delirium = ICDSC score \>/= 4\]
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Dexmedetomidine
Study Locations (2)
Massachusetts
- Tufts Medical Center - Boston
Quebec
- Maisonneuve Rosemont Hospital - Montreal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2011-01 |
| Est. Completion | 2016-12 |
| Phase | Phase 4 |
What the finished NCT01791296 record still lists
NCT01791296 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 2 conditions, with Delirium appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01791296 reports a single indexed study location in Massachusetts, Quebec.
Frequently Asked Questions
What is clinical trial NCT01791296 about?
NCT01791296 is a clinical study titled "Does Nightly Dexmedetomidine Improve Sleep and Reduce Delirium in ICU Patients?". Specific Aims 1. Establish the feasibility of larger trial by implementing a sleep protocol in the ICU at 2 different sites. Specifically will be estimating the recruitment rates of patients and the compliance with both interventions. 2. Measure the safety and tolerance of adding night-time sedatio...
What is the current status of trial NCT01791296?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2011-01. Estimated completion is 2016-12.
What conditions does trial NCT01791296 study?
This clinical trial studies the following conditions: Delirium, Sleep Deprivation.
What interventions are being tested in trial NCT01791296?
The interventions under investigation include: Placebo (OTHER), Dexmedetomidine (DRUG).
Who is sponsoring clinical trial NCT01791296?
This trial is sponsored by Maisonneuve-Rosemont Hospital, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01791296 being conducted?
This trial has 2 study locations across Massachusetts, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01791296'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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