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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:

Mortality

Vasopressor 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

Page last updated: August 20, 2015

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