Ketamine / Propofol Admixture "Ketofol" at Induction in the Critically Ill Against Etomidate: KEEP PACE Trial
Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Critical Illness
Intervention: Ketamine / Propofol Admixture (Drug); Etomidate (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: Mayo Clinic Official(s) and/or principal investigator(s): Nathan J Smischney, MD, Principal Investigator, Affiliation: Mayo Clinic
Overall contact: Richard F Hinds, MS, Phone: 507-538-4344, Email: hinds.richard@mayo.edu
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.
Clinical Details
Official title: Ketamine / Propofol Admixture "Ketofol" at Induction in the Critically Ill Against Etomidate: KEEP PACE Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Mean Arterial Pressure
Secondary outcome: MortalityVasopressor use adrenal insufficiency mechanical ventilation free days blood product transfusions
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 (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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Richard F Hinds, MS, Phone: 507-538-4344, Email: hinds.richard@mayo.edu
Mayo Clinic, Rochester, Minnesota 55905, United States; Recruiting Richard F Hinds, MS, Phone: 507-538-4344, Email: hinds.richard@mayo.edu Nathan J Smischney, MD, Principal Investigator
Additional Information
Starting date: April 2014
Last updated: May 14, 2015
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