Phase 3
Completed N=160
Ketamine / Propofol Admixture "Ketofol" at Induction in the Critically Ill Against Etomidate: KEEP PACE Trial
Source: ClinicalTrials.gov NCT02105415 ↗Enrolled (actual)
160
Serious AEs
7.2%
Results posted
Jan 2019
Primary outcomePrimary: Mean Arterial Pressure — 82.8; 80.9; 81.7; 77.6 mm Hg — p=0.385
◆ Published Evidence
Highly cited
105citations · ~15 / year
Ketamine/propofol admixture vs etomidate for intubation in the critically ill: KEEP PACE Randomized clinical trial.
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.
Linked Publications (3)
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Ketamine/propofol admixture vs etomidate for intubation in the critically ill: KEEP PACE Randomized clinical trial.
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Ketamine/propofol admixture (ketofol) at induction in the critically ill against etomidate (KEEP PACE trial): study protocol for a randomized controlled trial.
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Association of Shock Indices with Peri-Intubation Hypotension and Other Outcomes: A Sub-Study of the KEEP PACE Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Arterial Pressure |
82.8; 80.9; 81.7; 77.6; 81.9; 75.3 | 0.385 |
| SECONDARY Mortality |
26; 25 | 0.605 |
| SECONDARY Vasopressor Use |
1; 5; 12; 18; 57; 64 | 0.212 |
| SECONDARY Number of Participants With Adrenal Insufficiency |
13; 5; 9; 6 | — |
| SECONDARY Mechanical Ventilation Free Days |
22; 20 | 0.911 |
| SECONDARY Blood Product Transfusions |
21; 13; 16; 8; 28; 26 | 0.069 |
| SECONDARY Intensive Care Unit Free Days |
16; 17 | 0.994 |
| SECONDARY Number of Participants Experiencing Delirium Using Confusion Assessment Method in ICU |
7; 4 | 0.233 |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02105415) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.