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Pain, Agitation and Delirium (PAD) Protocol in the Duke CICU

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ClinicalTrials.gov Identifier: NCT02903407
Recruitment Status : Completed
First Posted : September 16, 2016
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Deep Sedation Ventilators, Mechanical Critical Illness Drug: Midazolam Drug: Propofol Drug: Dexmedetomidine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pain, Agitation and Delirium Protocol in Ventilated Patients in the Duke CICU
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
Active Comparator: Midazolam
IV midazolam will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.
Drug: Midazolam
IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.

Active Comparator: Propofol or Dexmedetomidine
Propofol or Dexmedetomidine per physician discretion will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.
Drug: Propofol
IV propofol will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.

Drug: Dexmedetomidine
IV dexmedetomidine will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.




Primary Outcome Measures :
  1. Intensive Care Unit Length of Stay [ Time Frame: Assessed at one month or hospital discharge, whichever time point comes first ]

Secondary Outcome Measures :
  1. In hospital mortality [ Time Frame: Assessed at one month or hospital discharge, whichever time point comes first ]
  2. Hospital length of stay [ Time Frame: Assessed at one month or hospital discharge, whichever time point comes first ]
  3. Increased vasopressor requirement [ Time Frame: Assessed at one month or hospital discharge, whichever time point comes first ]
    Patients will be monitored for increased pressor requirement which may be associated with sedation drug

  4. Bradycardia [ Time Frame: Assessed at one month or hospital discharge, whichever time point comes first ]
    Patients will be monitored for bradycardia which may be associated with sedation drug. Average heart rate before, during and after use of drug will be recorded for each patient.

  5. Number of ventilator days [ Time Frame: Assessed at one month or hospital discharge, whichever time point comes first ]
  6. Number of days from decision to extubate to true extubation [ Time Frame: Assessed at one month or hospital discharge, whichever time point comes first ]
  7. Number of days alive during admission and free from delirium or coma [ Time Frame: Assessed at one month or hospital discharge, whichever time point comes first ]
  8. Percentage of time at goal sedation [ Time Frame: Assessed at one month or hospital discharge, whichever time point comes first ]
    Will use RASS to assess level of sedation as per standard of care by nurses in the CICU. Data that is recorded will be evaluated following discharge.

  9. Time from withdrawal of sedation to ICU discharge [ Time Frame: Assessed at one month or hospital discharge, whichever time point comes first ]
  10. Delirium [ Time Frame: Assessed at one month or hospital discharge, whichever time point comes first ]
    Will use CAM-ICU score to assess delirium as per standard of care by nurses in the CICU. Data that is recorded will be evaluated following discharge.

  11. Pain Management [ Time Frame: Assessed at one month or hospital discharge, whichever time point comes first ]
    Will use CPOT score to assess pain level as per standard of care by nurses in the CICU. Data that is recorded will be evaluated following discharge.

  12. Reintubation [ Time Frame: Assessed at one month or hospital discharge, whichever time point comes first ]
    Following ICU discharge, patient charts will be reviewed to evaluate whether they required reintubation. If so, will determine whether necessity of reintubation was related to delirium



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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): NCT02903407


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University

Publications:

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02903407    
Other Study ID Numbers: Pro00074866
First Posted: September 16, 2016    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Duke University:
Ventilators, Mechanical
Intensive Care Units
Deep Sedation
Additional relevant MeSH terms:
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Delirium
Critical Illness
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Disease Attributes
Pathologic Processes
Midazolam
Dexmedetomidine
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action