A Phase 2 interventional study of Haloperidol in Delirium and Critical Illness, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-11-14.
Sponsored by University of Colorado, Denver · Phase 2, Interventional, and Treatment
The goal of this study is to determine whether haloperidol reduces the time on the breathing machine in critically ill patients with delirium.
Delirium is a frequent end-organ complication of critical illness and is an independent predictor of mortality in mechanically ventilated patients. However, management of delirium is a major therapeutic challenge and it is unknown if current therapies are disease modifying or function only as symptom management. Haloperidol has been demonstrated to reduce delirium in retrospective studies.
This study is a pilot prospective randomized clinical trial in the Denver Health Medical ICU to determine if haloperidol in addition to an evidence-based standard-of-care sedation protocol for the management of delirium results in a shortened duration of intubation and improvements in post-extubation cognitive status. The haloperidol dose is administered using titration-protocol guided by nursing assessment of delirium using the confusion assessment method for the ICU (CAM-ICU). The primary outcome is ventilator-free days out of the first 28, and secondary outcomes include duration of delirium, length and cost of hospitalization, 28-day mortality, usage of other sedatives, serum markers of delirium (neuron-specific enolase and protein S-100B), and cognitive-function scores at the time of ICU discharge, hospital discharge, and six-month follow-up.
The goal of the 20-patient pilot is demonstrating safety of the haloperidol protocol, as evaluated by an independent data-safety monitoring board. Following approval of the DSMB, 122 more patients will be enrolled in the full RCT to achieve power for an 80% chance of detecting a 40% decrease in duration of intubation with P \< 0.05.
1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.
This study's planned enrollment of 20 is below the median of 120 across 599 interventional studies indexed under Delirium.
Browse Delirium studies →University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Ventilator-free days out of the first 28
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
This study is completed, as verified in Nov 2009. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver