Clinical trial NCT02903407: Pain, Agitation and Delirium (PAD) Protocol in the Duke CICU
Official title: Pain, Agitation and Delirium Protocol in Ventilated Patients in the Duke CICU
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Deep Sedation
Ventilators, Mechanical
Critical Illness
Keywords: Ventilators, Mechanical
Intensive Care Units
Deep Sedation
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-09-16
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* All patients admitted to the Duke CICU, who require intubation and sedation for mechanical ventilation that is expected to be \>24 hours in duration will be included, unless they meet the specified exclusion criteria.
* Patients intubated within one hour prior to care transition to the CICU will also be screened for inclusion.

Exclusion Criteria:

* Exclusion criteria include patients following resuscitation from cardiac arrest who are treated on the cooling protocol
* patients who have suffered a neurologic event (seizure, stroke) or who have baseline dementia, both of which could limit delirium assessment
* patients with child class B and C liver disease
* patients with known allergy to study medications.

Primary outcomes:
measure: Intensive Care Unit Length of Stay
timeFrame: One month or hospital discharge, whichever time point comes first
Secondary outcomes:
measure: In Hospital Mortality
timeFrame: One month or hospital discharge, whichever time point comes first
measure: Hospital Length of Stay
timeFrame: One month or hospital discharge, whichever time point comes first
measure: Number of Participants With Increased Vasopressor Requirement
timeFrame: One month or hospital discharge, whichever time point comes first
measure: Number of Participants With Bradycardia
timeFrame: One month or hospital discharge, whichever time point comes first
measure: Number of Ventilator Days
timeFrame: One month or hospital discharge, whichever time point comes first
measure: Number of Days From Decision to Extubate to True Extubation
timeFrame: One month or hospital discharge, whichever time point comes first
measure: Number of Days Alive During Admission and Free From Delirium or Coma
timeFrame: One month or hospital discharge, whichever time point comes first
measure: Percentage of Time at Goal Sedation
timeFrame: One month or hospital discharge, whichever time point comes first
measure: Time From Withdrawal of Sedation to ICU Discharge
timeFrame: One month or hospital discharge, whichever time point comes first
measure: Number of Participants With Delirium
timeFrame: One month or hospital discharge, whichever time point comes first
measure: Pain Management
timeFrame: One month or hospital discharge, whichever time point comes first
measure: Number of Participants Requiring Reintubation
timeFrame: One month or hospital discharge, whichever time point comes first
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Kristin Newby, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Jakob SM, Ruokonen E, Grounds RM, Sarapohja T, Garratt C, Pocock SJ, Bratty JR, Takala J; Dexmedetomidine for Long-Term Sedation Investigators. Dexmedetomidine vs midazolam or propofol for sedation during prolonged mechanical ventilation: two randomized controlled trials. JAMA. 2012 Mar 21;307(11):1151-60. doi: 10.1001/jama.2012.304.