Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00429676
Status:
COMPLETED
Last Update Posted:
2012-11-14
First Post:
2007-01-30
Brief Title:
Pilot Study of Haloperidol to Treat Critical Illness Delirium
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
A Randomized Prospective Pilot Study Of Haloperidol In Addition To Standard Sedation In Mechanically Ventilated Patients With Delirium
Status:
COMPLETED
Status Verified Date:
2009-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to determine whether haloperidol reduces the time on the breathing machine in critically ill patients with delirium
Detailed Description:
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 005
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 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None