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

Mayo Clinic

Status and phase

Completed

Phase 3

Phase 2

Conditions

Critical Illness

Treatments

Drug: Etomidate

Drug: Ketamine / Propofol Admixture

Study type

Interventional

Funder types

Other

Identifiers

NCT02105415

13-000506

Details and patient eligibility

About

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.

Full 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.

Enrollment

160 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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.