Critical Illness Clinical Trial
Official title:
Pain, Agitation and Delirium Protocol in Ventilated Patients in the Duke CICU
This study aims to examine the use of protocol directed sedation using the Duke PAD protocol with the current sedation medications of propofol or dexmedetomidine compared to the PAD protocol with midazolam, per cardiac intensive care unit (CICU) usual care, as an initial step toward understanding the best management of sedation in these patients.
The optimal approach to management of sedation in the Intensive Care Unit (ICU) has become a
topic of increasing interest. The most recent guidelines outline the pharmacologic mechanisms
of commonly used medications as well as scales on which to measure goals of pain, sedation,
agitation and delirium in the critically ill patient. This guideline is based on a cadre of
randomized controlled trials examining the medications in the medical intensive care unit and
post cardiac surgery patient. Notably, in each of the trials, patients presenting with acute
myocardial infarction, heart failure or cardiogenic shock have been excluded or largely
underrepresented.
Using the current guidelines as a foundation, a new pain, agitation and delirium (PAD)
protocol, which prioritizes the use of propofol or dexmedetomidine for sedation, was
developed and instituted at Duke University Hospital. However, use of this protocol in the
CICU has raised important considerations. Some of these stem from the specific hemodynamic
characteristics of the population, including significant bradycardia and hypotension, which
can be worsened due to known side effects of propofol and dexmedetomidine. It remains unclear
whether the benefits of these medications outweigh the risks in CICU patients as the use of
these medications has not been studied previously in this population. This study aims to
examine the use of protocol directed sedation using the Duke PAD protocol with the current
sedation medications of propofol or dexmedetomidine compared to the PAD protocol with
midazolam, per CICU usual care, as an initial step toward understanding the best management
of sedation in these patients.
Project Aims Include:
1. Examine the efficacy of the PAD protocol using propofol or dexmedetomidine versus
midazolam with regard to goal sedation, pain control and level of delirium in intubated
Duke CICU patients.
2. Determine differences in duration of ventilator days, CICU stay and total hospital stay
with the PAD protocol using propofol or dexmedetomidine compared to midazolam in the
Duke CICU.
3. Compare the rates of adverse effects of the current PAD protocol with propofol or
dexmedetomidine versus midazolam for sedation in the Duke CICU, including hypotension,
bradycardia, difficulty with ventilator weaning due to sedation, and delirium.
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