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Haloperidol for Delirium in ICU (MIND)
NCT00429676Phase 2
Key facts
- Status
- Completed
- Start
- Dec 2005
- Primary completion
- Sep 2007
- Countries
- 1
- Sponsor
- University of Colorado Denver
- Modality
- Small Molecules
- Drugs
- haloperidol
- Conditions
- delirium
01
Overview
Phase 2, randomised, double-blind trial of haloperidol in delirium (2 arms), sponsored by University of Colorado Denver. Primary endpoint: Ventilator-free days out of the first 28 at 28 days. Started Dec 2005; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Haloperidol
Haloperidol + Standard Sedation
Standard Sedation
Placebo + Standard Sedation
03
Who it enrols
Mechanically ventilated patients with delirium, excluding those with dementia, seizures, or high risk of QTc prolongation.
04
Endpoints
Primary
Ventilator-free days out of the first 28
Secondary
Duration of delirium
Length of hospitalization
Cost of hospitalization
28-day mortality
Usage of other sedatives
Serum markers of delirium (neuron-specific enolase and protein S-100B)
Cognitive-function scores at the time of ICU discharge, hospital discharge, and six-month follow-up
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