A Phase 4 interventional study of Midazolam and Propofol in Deep Sedation, Ventilators, Mechanical and Critical Illness, sponsored by Duke University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-13.
Sponsored by Duke University · Phase 4, Interventional, and Treatment
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:
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Exclusion Criteria:
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
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 · Drug: Dexmedetomidine
IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
Also known as: Versed
IV propofol will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
Also known as: Diprivan
IV dexmedetomidine will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
Also known as: Precedex
Intensive Care Unit Length of Stay
Number of days of admission to the CICU during the index hospitalization
Time frame: One month or hospital discharge, whichever time point comes first
In Hospital Mortality
All-cause mortality during the hospitalization
Time frame: One month or hospital discharge, whichever time point comes first
Hospital Length of Stay
Index hospitalization length of stay in days
Time frame: One month or hospital discharge, whichever time point comes first
Number of Participants With Increased Vasopressor Requirement
Patients will be monitored for increased pressor requirement during the CICU stay
Time frame: One month or hospital discharge, whichever time point comes first
Number of Participants With Bradycardia
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.
Time frame: One month or hospital discharge, whichever time point comes first
Number of Ventilator Days
Days requiring mechanical ventilation during the initial episode of intubation during the hospitalization
Time frame: One month or hospital discharge, whichever time point comes first
Number of Days From Decision to Extubate to True Extubation
The time (in days) from when the clinical care team documents a decision to pursue extubation until the time the patient was extubated
Time frame: One month or hospital discharge, whichever time point comes first
Number of Days Alive During Admission and Free From Delirium or Coma
The number of days alive and free from delirium or coma during admission will be evaluated among patients with CAM-ICU documented
Time frame: One month or hospital discharge, whichever time point comes first
Percentage of Time at Goal Sedation
Will use RASS (Richmond Agitation and Sedation Scale) to assess level of sedation as per standard of care by nurses in the CICU. Data that is recorded will be evaluated following discharge. The RASS ranges from -5 (unrousable) to +4 (combative) and 0 (zero) = alert and calm and goal sedation is considered a RASS level of 0 to -2.
Time frame: One month or hospital discharge, whichever time point comes first
Time From Withdrawal of Sedation to ICU Discharge
The duration, in days, from withdrawal of sedation for mechanical ventilation until the time of discharge from the ICU
Time frame: One month or hospital discharge, whichever time point comes first
Number of Participants With Delirium
Will use the Confusion Assessment Method for the ICU (CAM-ICU) to assess presence of delirium as per standard of care by nurses in the CICU. Patients with CAM-ICU data recorded will be included.
Time frame: One month or hospital discharge, whichever time point comes first
Pain Management
Will use the CPOT (Critical-Care Pain Observation Tool) score to assess pain level as per standard of care by nurses in the CICU. The CPOT has a range of 0 to 8. A CPOT score of ≤ 2 = minimal to no pain present and \>2 = unacceptable level of pain. Data that is recorded will be evaluated following discharge.
Time frame: One month or hospital discharge, whichever time point comes first
Number of Participants Requiring Reintubation
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.
Time frame: One month or hospital discharge, whichever time point comes first
Patients were recruited from the Duke CICU between September 1, 2017 and June 30, 2019. Patients were identified by the rounding team for potential inclusion in the sedation trial and then screened by study team members to determine whether they met inclusion criteria. Consent was obtained from eligible patient's primary decision maker.
| Milestone | Midazolam | Propofol or Dexmedetomidine |
|---|---|---|
| Started | 4 | 3 |
| Completed | 4 | 3 |
| Not completed | 0 | 0 |
Number of days of admission to the CICU during the index hospitalization
| Days | Midazolam | Propofol or Dexmedetomidine |
|---|---|---|
| Intensive Care Unit Length of Stay | 4.1 (3.6 to 6.7) | 10.0 (8.2 to 10.3) |
All-cause mortality during the hospitalization
| participants | Midazolam | Propofol or Dexmedetomidine |
|---|---|---|
| In Hospital Mortality | 1 | 1 |
Index hospitalization length of stay in days
| Days | Midazolam | Propofol or Dexmedetomidine |
|---|---|---|
| Hospital Length of Stay | 19.5 (15.0 to 23.5) | 30.0 (21.5 to 35.0) |
Patients will be monitored for increased pressor requirement during the CICU stay
| Participants | Midazolam | Propofol or Dexmedetomidine |
|---|---|---|
| Number of Participants With Increased Vasopressor Requirement | 2 | 2 |
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.
| Participants | Midazolam | Propofol or Dexmedetomidine |
|---|---|---|
| Number of Participants With Bradycardia | 0 | 0 |
Days requiring mechanical ventilation during the initial episode of intubation during the hospitalization
| Days | Midazolam | Propofol or Dexmedetomidine |
|---|---|---|
| Number of Ventilator Days | 2.5 (2.1 to 4.2) | 6.8 (3.9 to 8.4) |
The time (in days) from when the clinical care team documents a decision to pursue extubation until the time the patient was extubated
| Days | Midazolam | Propofol or Dexmedetomidine |
|---|---|---|
| Number of Days From Decision to Extubate to True Extubation | 0 (0 to 0.25) | 0 (0 to 0) |
The number of days alive and free from delirium or coma during admission will be evaluated among patients with CAM-ICU documented
| Days | Midazolam | Propofol or Dexmedetomidine |
|---|---|---|
| Number of Days Alive During Admission and Free From Delirium or Coma | 14.0 (13.5 to 20.0) | — |
Will use RASS (Richmond Agitation and Sedation Scale) to assess level of sedation as per standard of care by nurses in the CICU. Data that is recorded will be evaluated following discharge. The RASS ranges from -5 (unrousable) to +4 (combative) and 0 (zero) = alert and calm and goal sedation is considered a RASS level of 0 to -2.
| percentage of time | Midazolam | Propofol or Dexmedetomidine |
|---|---|---|
| Percentage of Time at Goal Sedation | 63.3 (43.8 to 70.8) | 63.2 (56.6 to 64.4) |
The duration, in days, from withdrawal of sedation for mechanical ventilation until the time of discharge from the ICU
| Days | Midazolam | Propofol or Dexmedetomidine |
|---|---|---|
| Time From Withdrawal of Sedation to ICU Discharge | 1.6 (0.77 to 2.8) | 5.6 (2.8 to 5.8) |
Will use the Confusion Assessment Method for the ICU (CAM-ICU) to assess presence of delirium as per standard of care by nurses in the CICU. Patients with CAM-ICU data recorded will be included.
| Participants | Midazolam | Propofol or Dexmedetomidine |
|---|---|---|
| Number of Participants With Delirium | 1 | — |
Will use the CPOT (Critical-Care Pain Observation Tool) score to assess pain level as per standard of care by nurses in the CICU. The CPOT has a range of 0 to 8. A CPOT score of ≤ 2 = minimal to no pain present and \>2 = unacceptable level of pain. Data that is recorded will be evaluated following discharge.
| score on a scale | Midazolam | Propofol or Dexmedetomidine |
|---|---|---|
| Pain Management | 0.0 (0.0 to 0.5) | 0.0 (0.0 to 0.3) |
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.
| Participants | Midazolam | Propofol or Dexmedetomidine |
|---|---|---|
| Number of Participants Requiring Reintubation | 0 | 1 |
Collected over From time of enrollment to hospital discharge - a range of 2-29 days for the patients enrolled in the trial. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Midazolam | 1/4 (25%) | 0/4 (0%) | 0/4 (0%) |
| Propofol or Dexmedetomidine | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) |
| Age, Continuous(years) | Midazolam | Propofol or Dexmedetomidine | Total |
|---|---|---|---|
| Median | 72.5 (66.3 to 73.3) | 57.0 (55.5 to 63.5) | 70.0 (55.5 to 72.5) |
| Sex: Female, Male(Participants) | Midazolam | Propofol or Dexmedetomidine | Total |
|---|---|---|---|
| Female | 2 | 3 | 5 |
| Male | 2 | 0 | 2 |
| Race (NIH/OMB)(Participants) | Midazolam | Propofol or Dexmedetomidine | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 3 | 2 | 5 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Midazolam | Propofol or Dexmedetomidine | Total |
|---|---|---|---|
| United States | 4 | 3 | 7 |
| BMI(kg/m^2) | Midazolam | Propofol or Dexmedetomidine | Total |
|---|---|---|---|
| Median | 36.1 (33.2 to 38.5) | 34.4 (33.5 to 35.8) | 34.4 (33.3 to 37.7) |
| Ejection Fraction(Percentage of blood) | Midazolam | Propofol or Dexmedetomidine | Total |
|---|---|---|---|
| Median | 30.0 (18.8 to 43.8) | 55.0 (40.0 to 55.0) | 40.0 (22.5 to 55.0) |
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