Ketamine / Propofol Admixture "Ketofol" at Induction in the Critically Ill Against Etomidate: KEEP PACE Trial

NCT02105415 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 13-000506
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Critical Illness

Keywords

Critical care; Emergent; Etomidate; Hemodynamics; Intensive care unit; Intubation; Ketamine-Propofol admixture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Mortality

  Hospital Discharge or Day 28, whichever comes first

• Vasopressor Use

  up to 24 hours post study drug administration

• Number of Participants With Adrenal Insufficiency

  up to 24 hours post study drug administration

• Mechanical Ventilation Free Days

  hospital discharge or day 28, whichever comes first

• Blood Product Transfusions

  hospital discharge or day 28, whichever comes first

Study Arms (2)

Etomidate

ACTIVE COMPARATOR

weight based dose of 0.15mg/kg

Drug: Etomidate

Ketamine / Propofol Admixture

EXPERIMENTAL

weight based dose of 0.5mg/kg of ketamine and 0.5mg/kg of propofol

Drug: Ketamine / Propofol Admixture

Interventions

Ketamine / Propofol Admixture DRUG

Ketamine / Propofol Admixture

Etomidate DRUG

Etomidate

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (3)

• Smischney NJ, Seisa MO, Schroeder DR. Association of Shock Indices with Peri-Intubation Hypotension and Other Outcomes: A Sub-Study of the KEEP PACE Trial. J Intensive Care Med. 2024 Sep;39(9):866-874. doi: 10.1177/08850666241235591. Epub 2024 Feb 25.

  PMID: 38403984 DERIVED

• Smischney NJ, Nicholson WT, Brown DR, Gallo De Moraes A, Hoskote SS, Pickering B, Oeckler RA, Iyer VN, Gajic O, Schroeder DR, Bauer PR. Ketamine/propofol admixture vs etomidate for intubation in the critically ill: KEEP PACE Randomized clinical trial. J Trauma Acute Care Surg. 2019 Oct;87(4):883-891. doi: 10.1097/TA.0000000000002448.

  PMID: 31335755 DERIVED

• Smischney NJ, Hoskote SS, Gallo de Moraes A, Racedo Africano CJ, Carrera PM, Tedja R, Pannu JK, Hassebroek EC, Reddy DR, Hinds RF, Thakur L. Ketamine/propofol admixture (ketofol) at induction in the critically ill against etomidate (KEEP PACE trial): study protocol for a randomized controlled trial. Trials. 2015 Apr 21;16:177. doi: 10.1186/s13063-015-0687-0.

  PMID: 25909406 DERIVED

MeSH Terms

Conditions

Critical Illness

Interventions

Ketamine; Etomidate

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Single center study with non-blinded interventions and non-controlled co-interventions all of which can impact hemodynamics. Selection bias with 92 non-enrollees.

Results Point of Contact

• Title: Dr. Nathan Smischney
• Organization: Mayo Clinic

smischney.nathan@mayo.edu

507-255-4305

Study Officials

• Nathan J Smischney, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: March 31, 2014
• First Posted: April 7, 2014
• Study Start: April 1, 2014
• Primary Completion: November 28, 2017
• Study Completion: August 1, 2018
• Last Updated: June 16, 2020
• Results First Posted: January 11, 2019

Record last verified: 2020-05

Locations

US (1)