Detailed Summary of the EvK Clinical Trial

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 is being conducted at Parkland Hospital by clinicians and researchers in the Departments of Anesthesiology, Emergency Medicine, Medicine / Critical Care Medicine, Surgery, and Pharmacy. The study randomizes critically ill patients who require emergency endotracheal intubation to one of two groups: Etomidate or Ketamine. We are observing 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 has received Institutional Review Board (IRB) permission for "Exception-to-Informed Consent," which means that randomization of patients will happen without written consent. This website is being utilized to notify the public of this research project. This is in accordance with rules set forth by the U.S. Food and Drug Administration (FDA 21 CFR 50.24).


Contact Us:
Gerald Matchett, MD, Principal Investigator
Dept. of Anesthesiology & Pain Management
University of Texas-Southwestern Medical Center
5323 Harry Hines Blvd, Dallas, TX 75390-9068

214-648-6400

info@evktrial.org

gerald.matchett@utsouthwestern.edu​

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 Hospital are conducting a study to determine which medication is better for our patients. The purpose of this website is to inform the people of Dallas County about the EvK Clinical Trial. Enrollment in this clinical trial began on June 6, 2016 (UTSW IRB STU#022015-023, NTC02643381, www.evktrial.org)

About the EvK Clinical Trial Team


The EvK Clinical Trial Team is a large group of Anesthesiologists, Certified Nurse Anesthetists (CRNAs), Surgeons, Critical Care Physicians, Emergency Medicine Physicians, Pharmacists and others at UT-Southwestern Medical Center and Parkland Memorial Hospital who are dedicated to finding better ways to take care of critically ill patients. We hail from multiple clinical and academic departments, listed below. 


Gerald Matchett, MD (Principal Investigator)​​

Parkland Hospital

UT-Southwestern Medical Center

Dept. of Anesthesiology & Pain Management

Dept. of Medicine / Critical Care Medicine

Dept. of Emergency Medicine

Dept. of Surgery

Researchers and clinicians in the Departments of Anesthesiology, Emergency Medicine, Surgery, Medicine and Pharmacy at UT-Southwestern Medical Center and Parkland Hospital have started enrolling patients in the EvK Clinical Trial at Parkland Hospital in Dallas, TX. This clinical research could potentially affect anyone living or residing in Dallas County. The purpose of this website is to provide information about the clinical trial. Enrollment in this clinical trial began June 6, 2016. (UTSW IRB STU#022015-023NCT02643381, www.evktrial.org)


Etomidate versus Ketamine for Emergency Endotracheal Intubation: A Prospective Randomized Clinical Trial

Frequently Asked Questions:


1) Are etomidate and ketamine commonly used for sedation (or anesthesia) during emergency endotracheal intubation?

Yes. Both are commonly used, and both are the “standard-of-care” locally and nationally.

2) If both etomidate and ketamine are frequently used for this procedure, why are you doing the study?

There is considerable debate right now regarding which medication is better for patients. Each medication has side effects. We are trying to determine which is better for patients.

3) What does it mean to “randomize” a patient?

This means that individual patients who are enrolled in the study will receive either etomidate or ketamine. Which medication they will receive will depend on random chance, similar to what happens with a coin toss.

4) Besides receiving etomidate or ketamine, will patients in the study have any other study-related procedures?

No. The only intervention for the study is the choice of etomidate or ketamine, which will be done by random selection. Data will be gathered from the patient’s medical record after they enter the study, but this will not have any effect on medical care.

5) Why won’t patients have a chance to sign a consent form before enrolling in the study?

The EvK Trial is a study of an emergency medical procedure. The patients who are eligible for the study are critically ill and require immediate medical care (placement of a breathing tube), and therefore cannot give informed consent. After a patient is enrolled in the study, the study team will notify the patient and / or family of study enrollment, in accordance with FDA rules governing emergency medical research (FDA 21 CFR 50.24).

6) Is it legal to do a research study on a patient before he or she give written informed consent?

Yes, provided the study complies with the regulations governing this type of research. The U.S. Food and Drug Administration (FDA) has determined that in select cases of emergency research it is acceptable to do research without first obtaining written informed consent. Information about this can be found in the Documents section above, and at the FDA website.

7) Who is eligible to enroll in the study? Can patients volunteer for the study?

The EvK Trial will enroll patients who are critically ill, and specifically those who require emergency placement of a breathing tube. These patients are typically found in an emergency department, or intensive care unit, who are there under emergency circumstances. Because of this, individuals cannot volunteer for this study.

8) How was the public notified about the EvK Clinical Trial?

The U.S. Food and Drug Administration (FDA) requires that several specific measures be taken for research in emergency medical conditions. These measures are described in FDA 21 CFR 50.24. The EvK Trial investigators completed a comprehensive Community Consultation Plan that included this website, letters to more than 300 community leaders, social media, online advertising, newspaper advertising, and open Community Meetings. The open Community Meetings were held on April 4, 6 and 11, 2016. Information about our Community Consultation Plan can be found in the Documents tab above. Additional meetings and outreach will be scheduled if there is community interest. 

9) How many patients will enroll in the EvK Clinical Trial?

Approximately 825 patients will enroll.

10) Will the study investigators make money off the results of this study?

No. The EvK Trial collaborators do not have a financial stake in the outcome of the study. The study is primarily funded by the Dept. of Anesthesiology at the University of Texas-Southwestern Medical Center. Both medications used in the EvK Trial (etomidate and ketamine) are generic medications, and the study is not being done to market either medication. The EvK Trial is not a “for profit” study. No drug companies, or their agents or representatives, were involved in the design of this study, and none will be involved in the conduct of the study. 

11) How do I contact the research team if I have questions or concerns?

Gerald Matchett, MD, Principal Investigator
Dept. of Anesthesiology & Pain Management
University of Texas-Southwestern Medical Center
5323 Harry Hines Blvd, Dallas, TX 75390-9068
214-648-6400

info@evktrial.org
gerald.matchett@utsouthwestern.edu​


12) I would like to formally “opt-out” of the study. How do I do that?

Individuals who live or work in the catchment area of Parkland Hospital in Dallas, TX may “opt-out” of the study. To do this, please request to opt-out using the contact information above. You will be sent a custom MedAlert bracelet indicating this choice. The bracelet will be sent to you free of charge by mail.









13) Is this study approved by an Institutional Review Board (IRB)?

Yes. The UT-Southwestern IRB has reviewed the study (IRB Study Number STU#022015-023). The study is also approved by the Parkland Clinical Research Office (CRO). Detailed information is available in the "Documents" tab, above. The study is also registered on clinicaltrias.gov (study registration number NCT02643381).


14) How long will this clinical trial take?

Approximately 2-3 years

15) Will the results of this research be announced?

Yes. Results will be announced publicly through various methods, including publication in a scientific journal. No Protected Health Information (PHI) will be published or publicly disclosed.


16) My group or organization would like to schedule a meeting with Dr. Matchett. Can we do that?

Yes. Dr. Matchett will welcome the opportunity to discuss this clinical trial with any group, individual or organization. Please contact Dr. Matchett using one of the methods in the "Contact Us" link. ​​Translator services are available.

EvK Clinical Trial