This trial is active, not recruiting.

Condition critical illness
Treatments ketamine / propofol admixture, etomidate
Phase phase 2/phase 3
Sponsor Mayo Clinic
Start date April 2014
End date December 2016
Trial size 160 participants
Trial identifier NCT02105415, 13-000506


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
(Active Comparator)
ketamine / propofol admixture

Primary Outcomes

Mean Arterial Pressure
time frame: 15 minutes post study drug administration

Secondary Outcomes

time frame: Hosptial Discharge or Day 28, whichever comes first
Vasopressor use
time frame: up to 1 hour post study drug administration
adrenal insufficiency
time frame: up to 24 hours post study drug administration
mechanical ventilation free days
time frame: hospital discharge or day 28, whichever comes first
blood product transfusions
time frame: hospital discharge or day 28, whichever comes first

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Ketamine / Propofol Admixture "Ketofol" at Induction in the Critically Ill Against Etomidate: KEEP PACE Trial
Principal investigator Nathan J Smischney, MD
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 (MB-6B/G) and/or surgical intensive care unit (MB-7D/E) 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 15 minutes post-administration with secondary outcomes addressing intensive care unit length of stay, mortality, adrenal function, and vasoactive medication use, among others.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Mayo Clinic.