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Ketamine / Propofol Admixture "Ketofol" at Induction in the Critically Ill Against Etomidate: KEEP PACE Trial (KEEP PACE)

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ClinicalTrials.gov Identifier: NCT02105415
Recruitment Status : Completed
First Posted : April 7, 2014
Results First Posted : January 11, 2019
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Nathan J. Smischney, Mayo Clinic

Brief Summary:
The hypothesis of this study is that a Ketamine / Propofol mixture will produce more stable hemodynamics as compared to Etomidate during emergent intubations in the intensive care unit. Patients that require a breathing tube to be placed in the ICU will be randomized to receIve either a Ketamine / Propofol mixture or Etomidate for sedation in order to place the breathing tube.

Condition or disease Intervention/treatment Phase
Critical Illness Drug: Ketamine / Propofol Admixture Drug: Etomidate Phase 2 Phase 3

Detailed Description:
Endotracheal intubation is a procedure that may cause significant hemodynamic perturbations and can severely impact the outcome of the critically ill. To ensure a safe outcome during this particular procedure, there are many factors that the clinician is faced with. One decision that confronts the critical care physician involves the correct combination of medications with which to facilitate such a safe outcome. Given the reported hemodynamic stability, etomidate is a medication that is chosen by many providers in this particular situation. However, its association with a possible increase in mortality makes it less than ideal for a number of critical care physicians. In recent years, an admixture of propofol and ketamine has been studied that demonstrates hemodynamic stability based on the balancing of the hemodynamic effects of these two individual agents alone. This novel medication combination, sometimes referred to as "ketofol", may offer a valuable alternative to the critical care physician. Therefore, a randomized parallel-group clinical trial of adult critically ill patients admitted to a medical and/or surgical intensive care unit at Mayo Clinic Rochester who meet the criteria designated below for which urgent and/or emergent intubation is needed will receive one of two interventions based on stratified randomization. The "active" intervention arm will receive ketamine/propofol (ketofol) to facilitate endotracheal intubation. The comparison arm will receive etomidate. The primary outcome will focus on hemodynamic data recorded during the first 5 minutes post-administration with secondary outcomes looking at hemodynamic data at 10 and 15 minutes and addressing intensive care unit length of stay, mortality, adrenal function, and vasoactive medication use, among others.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ketamine / Propofol Admixture "Ketofol" at Induction in the Critically Ill Against Etomidate: KEEP PACE Trial
Study Start Date : April 2014
Actual Primary Completion Date : November 28, 2017
Actual Study Completion Date : August 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Etomidate
weight based dose of 0.15mg/kg
Drug: Etomidate
Experimental: Ketamine / Propofol Admixture
weight based dose of 0.5mg/kg of ketamine and 0.5mg/kg of propofol
Drug: Ketamine / Propofol Admixture



Primary Outcome Measures :
  1. Mean Arterial Pressure [ Time Frame: baseline and every 5 minutes up to 15 minutes minutes post study drug administration ]
    Mean arterial pressure for the ketamine/propofol group at a 1:1 dose ratio compared to the etomidate group within the first 15 minutes post-administration in patients in need of urgent and/or emergent endotracheal intubation, as defined by any intubation within the intensive care unit excluding intubations for elective procedural events and codes.


Secondary Outcome Measures :
  1. Mortality [ Time Frame: Hospital Discharge or Day 28, whichever comes first ]
    In-hospital/28 day mortality among patients in ketamine/propofol combination compared to in-hospital/28-day mortality in etomidate.

  2. Vasopressor Use [ Time Frame: up to 24 hours post study drug administration ]
    The use of vasoactive medications to restore the blood pressure post-administration in the ketamine/propofol combination as compared to the etomidate group.

  3. Number of Participants With Adrenal Insufficiency [ Time Frame: up to 24 hours post study drug administration ]
    Incidence of adrenal insufficiency between ketamine/propofol admixture and etomidate. Adrenal insuffiency was evaluated with co-syntropin stimulation test.

  4. Mechanical Ventilation Free Days [ Time Frame: hospital discharge or day 28, whichever comes first ]
    comparison of mechanical ventilation free days between the two groups

  5. Blood Product Transfusions [ Time Frame: hospital discharge or day 28, whichever comes first ]
    blood product transfusions [Red Blood Cells vs. non-Red Blood Cells] between the two groups

  6. Intensive Care Unit Free Days [ Time Frame: hospital discharge or day 28, whichever comes first ]
    comparison of intensive care unit free days between the two groups

  7. Number of Participants Experiencing Delirium Using Confusion Assessment Method in ICU [ Time Frame: up to 24 hours post study drug administration ]
    Comparison of number of participants who were positive for delirium using CAM-ICU between groups



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Surgical or medical intensive care unity patients requiring endotracheal intubation
  • Consulting physician agrees to study plan and will follow drug randomization

Exclusion Criteria:

  • Known intracranial pathology
  • Known chronic opiate-dependence
  • Received continuous sedative infusion in the last 24 hours
  • Known severe psychiatric illness
  • Known egg allergies
  • Known contraindication to fentanyl, midazolam, ketamine, propofol or etomidate
  • Intubation in which standard practice is not to use sedation
  • No known documented weight or weight greater than 140 kg or less than 30 kg
  • Prior participation in the study
  • Of childbearing age (18-50) with no known negative pregnancy test on this admission.

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): NCT02105415


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Nathan J Smischney, MD Mayo Clinic
  Study Documents (Full-Text)

Documents provided by Nathan J. Smischney, Mayo Clinic:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nathan J. Smischney, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02105415    
Other Study ID Numbers: 13-000506
First Posted: April 7, 2014    Key Record Dates
Results First Posted: January 11, 2019
Last Update Posted: January 11, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nathan J. Smischney, Mayo Clinic:
Critical care
Emergent
Etomidate
Hemodynamics
Intensive care unit
Intubation
Ketamine-Propofol admixture
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes
Ketamine
Propofol
Etomidate
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action