EvK Clinical Trial
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, NCT02643381, www.evktrial.org)
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#022015-023, NCT02643381, www.evktrial.org)
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 Clinical 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-from-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).
Etomidate versus Ketamine for Emergency Endotracheal Intubation: A Prospective Randomized Clinical Trial