Ketamine / Propofol Admixture "Ketofol" at Induction in the Critically Ill Against Etomidate: KEEP PACE Trial
- Conditions
- Critical Illness
- Interventions
- Registration Number
- NCT02105415
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ketamine / Propofol Admixture Ketamine / Propofol Admixture weight based dose of 0.5mg/kg of ketamine and 0.5mg/kg of propofol Etomidate Etomidate weight based dose of 0.15mg/kg
- Primary Outcome Measures
Name Time Method Mean Arterial Pressure 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
Name Time Method Mortality 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.
Blood Product Transfusions hospital discharge or day 28, whichever comes first blood product transfusions \[Red Blood Cells vs. non-Red Blood Cells\] between the two groups
Intensive Care Unit Free Days hospital discharge or day 28, whichever comes first comparison of intensive care unit free days between the two groups
Number of Participants Experiencing Delirium Using Confusion Assessment Method in ICU up to 24 hours post study drug administration Comparison of number of participants who were positive for delirium using CAM-ICU between groups
Mechanical Ventilation Free Days hospital discharge or day 28, whichever comes first comparison of mechanical ventilation free days between the two groups
Number of Participants With Adrenal Insufficiency 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.
Vasopressor Use 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.
Trial Locations
- Locations (1)
Mayo Clinic
đŸ‡ºđŸ‡¸Rochester, Minnesota, United States