Clinical trial NCT02105415: Ketamine / Propofol Admixture "Ketofol" at Induction in the Critically Ill Against Etomidate: KEEP PACE Trial
Official title: Ketamine / Propofol Admixture "Ketofol" at Induction in the Critically Ill Against Etomidate: KEEP PACE Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Critical Illness
Keywords: Critical care
Emergent
Etomidate
Hemodynamics
Intensive care unit
Intubation
Ketamine-Propofol admixture
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2014-04-07
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Mean Arterial Pressure
timeFrame: baseline and every 5 minutes up to 15 minutes minutes post study drug administration
Secondary outcomes:
measure: Mortality
timeFrame: Hospital Discharge or Day 28, whichever comes first
measure: Vasopressor Use
timeFrame: up to 24 hours post study drug administration
measure: Number of Participants With Adrenal Insufficiency
timeFrame: up to 24 hours post study drug administration
measure: Mechanical Ventilation Free Days
timeFrame: hospital discharge or day 28, whichever comes first
measure: Blood Product Transfusions
timeFrame: hospital discharge or day 28, whichever comes first
measure: Intensive Care Unit Free Days
timeFrame: hospital discharge or day 28, whichever comes first
measure: Number of Participants Experiencing Delirium Using Confusion Assessment Method in ICU
timeFrame: up to 24 hours post study drug administration
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Nathan J Smischney, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smischney NJ, Nicholson WT, Brown DR, Gallo De Moraes A, Hoskote SS, Pickering B, Oeckler RA, Iyer VN, Gajic O, Schroeder DR, Bauer PR. Ketamine/propofol admixture vs etomidate for intubation in the critically ill: KEEP PACE Randomized clinical trial. J Trauma Acute Care Surg. 2019 Oct;87(4):883-891. doi: 10.1097/TA.0000000000002448.
citation: Smischney NJ, Hoskote SS, Gallo de Moraes A, Racedo Africano CJ, Carrera PM, Tedja R, Pannu JK, Hassebroek EC, Reddy DR, Hinds RF, Thakur L. Ketamine/propofol admixture (ketofol) at induction in the critically ill against etomidate (KEEP PACE trial): study protocol for a randomized controlled trial. Trials. 2015 Apr 21;16:177. doi: 10.1186/s13063-015-0687-0.