Pilot Study of Haloperidol to Treat Critical Illness Delirium
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|ClinicalTrials.gov Identifier: NCT00429676|
Recruitment Status : Completed
First Posted : February 1, 2007
Last Update Posted : November 14, 2012
|Condition or disease||Intervention/treatment||Phase|
|Delirium Critical Illness||Drug: Haloperidol||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Prospective Pilot Study Of Haloperidol In Addition To Standard Sedation In Mechanically Ventilated Patients With Delirium|
|Study Start Date :||December 2005|
|Actual Primary Completion Date :||September 2007|
|Actual Study Completion Date :||September 2007|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00429676
|United States, Colorado|
|Denver Health Medical Center|
|Denver, Colorado, United States, 80204|
|Principal Investigator:||Ivor S Douglas, MD||University of Colorado Department of Pulmonary and Critical Care Medicine|