Critical Illness Clinical Trial
Official title:
A Randomized Prospective Pilot Study Of Haloperidol In Addition To Standard Sedation In Mechanically Ventilated Patients With Delirium
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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