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

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.

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.