Etomidate Versus Ketamine for Emergency Endotracheal Intubation: a Prospective Randomized Clinical Trial (EvK)

• ClinicalTrials.gov Identifier: NCT02643381
• Recruitment Status: Recruiting
• First Posted: December 31, 2015
• Last Update Posted: January 17, 2019
• Sponsor: University of Texas Southwestern Medical Center
• Information provided by (Responsible Party): University of Texas Southwestern Medical Center

Tracking Information

• First Submitted Date: December 11, 2015
• First Posted Date: December 31, 2015
• Last Update Posted Date: January 17, 2019
• Actual Study Start Date: June 6, 2016
• Estimated Primary Completion Date: January 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 29, 2015)

Survival [ Time Frame: Day 7 ]

Survival at day 7 following emergency endotracheal intubation.

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT02643381 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: December 29, 2015)

• Survival [ Time Frame: Day 28 ]
  Survival at day 28 following emergency endotracheal intubation.
• Sequential Organ Failure Assessment (SOFA) scores [ Time Frame: Day 0-28 ]
  SOFA scores following emergency endotracheal intubation.
• Immediate outcomes of endotracheal intubation. [ Time Frame: Day 0 ]
  Each intubation will be assessed for specific immediate outcomes including the following: Number of attempts required to successfully intubate the patient and the presence or absence of specific traumatic complications that are known risks of the procedure including oral / dental trauma, bleeding, and/or aspiration.
• Duration of mechanical ventilation. [ Time Frame: Day 0-28 ]
  Duration of mechanical ventilation.
• Duration of catecholamine therapy [ Time Frame: Day 0-28 ]
  Duration of catecholamine therapy
• Length of stay in ICU / hospital [ Time Frame: Day 0-28 ]
  Length of stay in ICU / hospital
• New diagnosis of adrenal insufficiency [ Time Frame: Day 0-28 ]
  Specific testing for adrenal insufficiency will not be performed as part of the study. However, the charts of all patients enrolled in the study will be assessed to see if the primary treating medical or surgical team has made a diagnosis of adrenal insufficiency. The total number of subjects with this new diagnosis will be recorded.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Etomidate Versus Ketamine for Emergency Endotracheal Intubation: a Prospective Randomized Clinical Trial
• Official Title: Etomidate Versus Ketamine for Emergency Endotracheal Intubation: a Prospective Randomized Clinical Trial
• Brief Summary: Patients who are having problems breathing sometimes require placement of a breathing tube in their mouth and windpipe. The purpose of this breathing tube is to save the patient's life. It is common to give the patient a medication to sedate him or her before the breathing tube is placed. For patients who are gravely ill two medications are commonly used: etomidate or ketamine. Both medications have risks and benefits. Researchers at UT-Southwestern Medical Center and Parkland Memorial Hospital would like to do a study to figure out which one is better for our patients.

Detailed Description

Critically ill individuals who require emergency endotracheal intubation (placement of a breathing tube in the patient's mouth) usually require sedation or anesthesia to make this process tolerable. There are several medication choices for anesthesia, including medications like etomidate, ketamine and propofol. Of these, etomidate and ketamine are frequently used for critically ill patients because they have minimal effects on the patient's vital signs (blood pressure and heart rate). Both etomidate and ketamine are standard-of-care medications, locally and nationally, and both are frequently used to sedate a patient for this procedure. Both etomidate and ketamine have potential side effects. One of the potential side effects of etomidate is suppression of adrenal gland function. It is not known if this affects patients' outcomes in significant ways. One of the potential side effects of ketamine is a slight increase in patients' heart rates. It is not known if this affects patients' outcomes in significant ways.

The EvK Trial will be conducted at Parkland Memorial Hospital by investigators in the Departments of Anesthesiology, Emergency Medicine, Medicine / Critical Care Medicine, Surgery, and Pharmacy. The study will randomize critically ill patients who require emergency endotracheal intubation to one of two groups: Etomidate or Ketamine. We will observe the patients' outcomes. The only study intervention involves randomizing individual patients to one medication or the other. All study follow-up beyond that point is done by review of medical records.

Because of the nature of this study - an emergency procedure on a critically ill patient - the study will require institutional review board permission not to obtain written informed consent from the patient prior to randomization of study drug for administration for endotracheal tube placement. Prior to enrollment of patients the study team will carry out a comprehensive Community Consultation Plan, which is designed to inform the community about the research study. This is in accordance with rules set forth by the U.S. Food and Drug Administration (FDA 21 CFR 50.24).

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Cardiopulmonary Arrest
• Respiratory Arrest

Intervention

• Drug: Etomidate
  Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation.
• Drug: Ketamine
  Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation.
• Procedure: Emergency Endotracheal Intubation
  Patients enrolled in the study will be endotracheally intubated. (A breathing tube will be placed into the patient's mouth and trachea). This procedure is being done as part of standard emergency care. Standard endotracheal tubes will be used. Our hospital uses primarily Mallinckrodt (TM) brand endotracheal tubes.
• Device: Mechanical Ventilation
  Patients enrolled in the study will be mechanically ventilated, using a standard ventilator used in our hospital. The mechanical ventilator is attached to the patient's endotracheal tube and helps sustain the patient's life. Our hospital uses several brands of mechanical ventilators.

Study Arms

• Experimental: Etomidate
  Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation.
  Interventions:

  • Drug: Etomidate
  • Procedure: Emergency Endotracheal Intubation
  • Device: Mechanical Ventilation
• Experimental: Ketamine
  Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation.
  Interventions:

  • Drug: Ketamine
  • Procedure: Emergency Endotracheal Intubation
  • Device: Mechanical Ventilation

• Publications *: Matchett G, Ryan TJ, Sunna MC, Lee SC, Pepe PE; EvK Clinical Trial Group. Measuring the cost and effect of current community consultation and public disclosure techniques in emergency care research. Resuscitation. 2018 Jul;128:37-42. doi: 10.1016/j.resuscitation.2018.04.033. Epub 2018 Apr 30.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 29, 2015): 825
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 2023
• Estimated Primary Completion Date: January 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Adult patient (male or female) requiring emergency endotracheal intubation.

Exclusion Criteria:

• Children (<18 years old).
• Women who are known to be pregnant.
• Any patient who has been previously randomized in the EvK Trial.
• Patients who require endotracheal intubation without sedative medication. For example, patients in full cardiac arrest.
• Patients with a known allergy to ketamine or etomidate.
• Any individual wearing a MedAlert bracelet indicating that he/she has formally opted out of the EvK Trial.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Gerald Matchett, MD; 214-648-6400; info@evktrial.org

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02643381
• Other Study ID Numbers: 022015-023
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: Aggregate anonymous data will be published in accord with our IRB approval.

• Responsible Party: University of Texas Southwestern Medical Center
• Study Sponsor: University of Texas Southwestern Medical Center
• Collaborators: Not Provided

Investigators

• Principal Investigator: Gerald Matchett, MD; University of Texas

• PRS Account: University of Texas Southwestern Medical Center
• Verification Date: January 2019