Critical Illness Clinical Trial
— KEEP PACEOfficial title:
Ketamine / Propofol Admixture "Ketofol" at Induction in the Critically Ill Against Etomidate: KEEP PACE Trial
Verified date | May 2020 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 160 |
Est. completion date | August 1, 2018 |
Est. primary completion date | November 28, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean Arterial Pressure | Mean arterial pressure for the ketamine/propofol group at a 1:1 dose ratio compared to the etomidate group within the first 15 minutes post-administration in patients in need of urgent and/or emergent endotracheal intubation, as defined by any intubation within the intensive care unit excluding intubations for elective procedural events and codes. | baseline and every 5 minutes up to 15 minutes minutes post study drug administration | |
Secondary | Mortality | In-hospital/28 day mortality among patients in ketamine/propofol combination compared to in-hospital/28-day mortality in etomidate. | Hospital Discharge or Day 28, whichever comes first | |
Secondary | Vasopressor Use | The use of vasoactive medications to restore the blood pressure post-administration in the ketamine/propofol combination as compared to the etomidate group. | up to 24 hours post study drug administration | |
Secondary | Number of Participants With Adrenal Insufficiency | Incidence of adrenal insufficiency between ketamine/propofol admixture and etomidate. Adrenal insuffiency was evaluated with co-syntropin stimulation test. | up to 24 hours post study drug administration | |
Secondary | Mechanical Ventilation Free Days | comparison of mechanical ventilation free days between the two groups | hospital discharge or day 28, whichever comes first | |
Secondary | Blood Product Transfusions | blood product transfusions [Red Blood Cells vs. non-Red Blood Cells] between the two groups | hospital discharge or day 28, whichever comes first | |
Secondary | Intensive Care Unit Free Days | comparison of intensive care unit free days between the two groups | hospital discharge or day 28, whichever comes first | |
Secondary | Number of Participants Experiencing Delirium Using Confusion Assessment Method in ICU | Comparison of number of participants who were positive for delirium using CAM-ICU between groups | up to 24 hours post study drug administration |
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