Ketamine / Propofol Admixture "Ketofol" at Induction in the Critically Ill Against Etomidate: KEEP PACE Trial (KEEP PACE)
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|ClinicalTrials.gov Identifier: NCT02105415|
Recruitment Status : Completed
First Posted : April 7, 2014
Results First Posted : January 11, 2019
Last Update Posted : January 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Critical Illness||Drug: Ketamine / Propofol Admixture Drug: Etomidate||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Ketamine / Propofol Admixture "Ketofol" at Induction in the Critically Ill Against Etomidate: KEEP PACE Trial|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||November 28, 2017|
|Actual Study Completion Date :||August 1, 2018|
Active Comparator: Etomidate
weight based dose of 0.15mg/kg
Experimental: Ketamine / Propofol Admixture
weight based dose of 0.5mg/kg of ketamine and 0.5mg/kg of propofol
Drug: Ketamine / Propofol Admixture
- Mean Arterial Pressure [ Time Frame: baseline and every 5 minutes up to 15 minutes minutes post study drug administration ]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.
- Mortality [ Time Frame: Hospital Discharge or Day 28, whichever comes first ]In-hospital/28 day mortality among patients in ketamine/propofol combination compared to in-hospital/28-day mortality in etomidate.
- Vasopressor Use [ Time Frame: up to 24 hours post study drug administration ]The use of vasoactive medications to restore the blood pressure post-administration in the ketamine/propofol combination as compared to the etomidate group.
- Number of Participants With Adrenal Insufficiency [ Time Frame: up to 24 hours post study drug administration ]Incidence of adrenal insufficiency between ketamine/propofol admixture and etomidate. Adrenal insuffiency was evaluated with co-syntropin stimulation test.
- Mechanical Ventilation Free Days [ Time Frame: hospital discharge or day 28, whichever comes first ]comparison of mechanical ventilation free days between the two groups
- Blood Product Transfusions [ Time Frame: hospital discharge or day 28, whichever comes first ]blood product transfusions [Red Blood Cells vs. non-Red Blood Cells] between the two groups
- Intensive Care Unit Free Days [ Time Frame: hospital discharge or day 28, whichever comes first ]comparison of intensive care unit free days between the two groups
- Number of Participants Experiencing Delirium Using Confusion Assessment Method in ICU [ Time Frame: up to 24 hours post study drug administration ]Comparison of number of participants who were positive for delirium using CAM-ICU between groups
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105415
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Nathan J Smischney, MD||Mayo Clinic|