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NCT01174290 · ClinicalTrials.gov registry record · Phase 4
Preventing ICU Subsyndromal Delirium Conversion to Delirium With Haloperidol
A Phase 4 study, sponsored by Northeastern University.
- Completed
- Registry status
- Phase 4
- Development phase
- 68
- Enrollment target
NCT01174290: Completed Phase 4 study, sponsored by Northeastern University.
NCT01174290 is a Phase 4 study that has completed, run by Northeastern University. The registered enrollment target is 68 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01174290, a Phase 4 study, has completed, sponsored by Northeastern University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 68 participants
- Enrollment target
Study Summary
About one-third of the patients who develop mild, acute confusion (i.e., subsyndromal delirium) will go on to develop a severe acute confusional state (i.e. delirium). Delirium refers to a temporary change in the way a person thinks about things. Delirium occurs in patients admitted to the hospital particularly those patients that are very sick, who are given a number of medications, and who are not able to sleep normally. It affects their behavior, their understanding of the people and things around them, and their ability to make decisions. While ICU doctors do everything possible to eliminate the factors that may cause delirium, delirium may cause a person to become very agitated which if not controlled is dangerous to their safety as well as the safety of those around them. As well, if delirium develops in patients in the ICU, it may increase the risk for death, keep patients in both the ICU and hospital for longer and send patients to a long term care facility rather than home after they are discharged from the hospital. A recent medical report found that patients in the ICU who develop subsyndromal delirium have a mortality rate, a length of stay in both the ICU and the hospital, and a transfer rate to a long term care facility that is nearly as great as patients with delirium and greater than patients who develop neither subsyndromal delirium or delirium. Recent studies in non-ICU patients suggest that if a patient who is at high risk for developing delirium receives a medication called an antipsychotic (e.g. haloperidol) they may not be as likely to develop delirium or if they do develop delirium it will not last as long. No studies have evaluated the effect of administering an antipsychotic in patients in the ICU who have subsyndromal delirium. Another study completed in the ICUs at Tufts Medical Center found that there may be an association between the development of delirium in patients with subsyndromal delirium and the use of haloperidol. However, this
Primary Outcome
To determine the effect of haloperidol administration in critically ill patients with subsyndromal delirium (ICDSC 1-3) on conversion to delirium (ICDSC \>/=4) that is confirmed by a pyschiatrist using DSM-IV criteria) during the period that study drug is administered (up to 10 days).
Interventions
- DRUG Placebo
- DRUG Haloperidol decanoate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2010-09 |
| Est. Completion | 2014-03 |
| Phase | Phase 4 |
What the finished NCT01174290 record still lists
NCT01174290 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01174290 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01174290 about?
NCT01174290 is a clinical study titled "Preventing ICU Subsyndromal Delirium Conversion to Delirium With Haloperidol". About one-third of the patients who develop mild, acute confusion (i.e., subsyndromal delirium) will go on to develop a severe acute confusional state (i.e. delirium). Delirium refers to a temporary change in the way a person thinks about things. Delirium occurs in patients admitted to the hospital ...
What is the current status of trial NCT01174290?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 68 participants. The study started on 2010-09. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01174290?
The interventions under investigation include: Placebo (DRUG), Haloperidol decanoate (DRUG).
Who is sponsoring clinical trial NCT01174290?
This trial is sponsored by Northeastern University, which has 39 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01174290's enrollment target sits among peer trials
68 1076th of 2000 higher than 918 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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