Research: Moving forward in the field

The UC Davis Department of Emergency Medicine has served the medical center and surrounding community since 1973. Prior to 1990, the Department's primary focus was the education of medical students/residents and patient care. However, over the past eighteen years the Department of Emergency Medicine has increasingly contributed to the growing body of medical research in the field of emergency medicine.

Recent grants that have been awarded to the Department of Emergency Medicine include awards of $2.4 million for a pediatric emergency medicine network (PECARN), $3.7 million to study the causes, consequences and prevention of violence, and $745,000 to study brain injury in older adults taking anticoagulants. Another $16 million worth of grants is pending review.

As the number of publications has increased, so has the breadth of research topics. This sharp increase in the number of publications clearly illustrates the intensifying faculty interest in conducting research.  

Seizures are one of the most common reasons people call 9-1-1 for children. Seizures that do not stop on their own can be life-threatening. Paramedics are Emergency Medical Services (EMS) clinicians who are trained to treat seizures with a benzodiazepine medication called midazolam. Midazolam is a proven treatment paramedics already use to stop a seizure quickly, but delays in administering midazolam occur when paramedics must perform multi-step calculations to determine the dose or try to insert an intravenous line in a child. Unfortunately, these delays mean that approximately half of children receive the wrong dose, usually an underdose. Delayed and underdosed medication result in 1/3 of these children arriving via ambulance to the emergency department (ED) still seizing. The Pediatric Dose Optimization for Seizures in EMS (PediDOSE) trial evaluates whether an age-based, calculation-free method of quickly giving the right midazolam dose improves outcomes in children. Manish Shah, M.D. is the Principal Investigator for PediDOSE, and the study aims to decrease the number of children arriving at the ED with an ongoing seizure while maintaining patient safety.

EMS agencies participating in this study will replace conventional methods for calculating the midazolam dose with a new standardized treatment plan. Researchers will collect information about children ages 6 months to 13 years transported by Sacramento Fire Department and Sacramento Metro Fire Department to UC Davis Emergency Department for active seizures. It is exciting that the Sacramento community is one of 20 locations across the country that will enroll patients over a four-year period. Over the course of the study, the participating EMS agencies will be randomly assigned a timeline for adopting the standardized treatment plan. This will allow researchers to compare the new standardized treatment plan to current methods and ensure safe implementation of the new standardized protocol.

A child experiencing an ongoing seizure is having a life-threatening emergency. These situations can be stressful for parents and require a paramedic’s complete focus. Therefore, it will not be possible to obtain permission from parents to have their child enrolled in the study before treatment is given. This means that eligible children will be enrolled under an exception from informed consent (EFIC) process that follows federal rules for emergency research, has been approved by a research ethics review board, and has been used for other EMS-based studies in both children and adults. Parents or guardians of children enrolled in this study will be notified about their children’s participation after enrollment.

PediDOSE Contact Information:
Site Principal Investigator: Daniel Nishijima, M.D.
Email: pedidose@ucdavis.edu
Website: https://www.texaschildrens.org/pedidose-study

There are approximately 75,000 children with sepsis each year in the U.S. Sepsis is a dangerous infection that can be life threatening. Sepsis can affect many different parts of the body including the heart, lungs, liver, kidney, blood, and brain. Sepsis can cause damage to any of these organs and can prevent a person from returning to school or work or from functioning independently. Sepsis can cause permanent organ damage or even death. Quick recognition and treatment of sepsis with IV fluids and antibiotics can help to improve survival.

PROMPT BOLUS is an emergency medicine study designed to compare two different commonly used treatments to see if one is safer and more effective than the other.

Emergency department care of these patients is not the same everywhere in the US, but always involves a combination of antibiotics and IV fluids. Doctors use their judgment about which type of IV fluid is best for sepsis, but a definite answer is not known. The PROMPT BOLUS study plans to look at two commonly used IV fluid types given in emergency departments and intensive care units to treat sepsis to determine which one is most effective. These two fluid types are Normal Saline (NS) and Balanced Fluids (BF, including lactated Ringer’s and Plasma-Lyte). Although all study patients will receive a fluid type that is effective, safe, and recommended for treatment of sepsis, the reason for this study is to determine which fluid may be the most effective and safest. Therefore, if there are differences in effectiveness and safety, then length of stay in hospital may be different between groups and one fluid type may have higher mortality than the other. Whenever possible, researchers get permission before a person can be included in a study. But when a person has sepsis, it can be difficult to give consent. Also, since sepsis must be treated quickly, there is often not be enough time to locate and talk to the person’s parent or guardian about the study. So, we expect that most patients will be enrolled in the study without his/her parent or guardian’s consent. This is called “Exception from Informed Consent” (EFIC). Once the parent or guardian is located or the patient improves, they will be told about the study and asked to give their permission to continue in the study.

We are not aware of any reason, at this time, why anyone with sepsis would not choose to participate if awake and able to take part in decisions about their care. All patients enrolled in the study will receive one of the two commonly used IV fluid types to treat sepsis along with the best locally available medical care available for their symptoms.

The purpose of this handout is to notify our community about this trial, to provide contact information and resources where you can learn more, including an option to decline participation.

PROMPT BOLUS Contact Information:
Site Principal Investigator: Cheryl Vance, M.D.
Email: promptbolus@ucdavis.edu
Website: https://promptbolus.research.chop.edu