Emergency Services Clinical Research

Nationwide Children’s Hospital is studying the effects of concussions by measuring the levels of cortisol, a stress hormone, in children’s hair and saliva. We are looking for children who have not had a concussion to participate in the study.

Who can take part in this study?

Healthy children 8 to 18 years old with hair at least two inches long who have not had a concussion in the last 12 months and have no current extremity injuries.

What will happen during the study?

Qualified children will participate in one of two groups – an exercise or non-exercise group.

Children placed in the exercise group will:

• Complete a 45-minute enrollment visit
• Attend three 90-minute visits over a two month period where they will exercise on a treadmill and submit saliva samples
• Complete a 100-minute exercise and wrap-up visit

Children placed in the non-exercise group will:

• Complete a 45-minute enrollment visit
• Submit an online questionnaire two weeks and four weeks after the enrollment visit
• Complete a 45-minute wrap-up visit

Will we be paid for the study?

Yes, families will be paid for taking part in the study

For more information or to enroll your child, contact Olivia Groves via phone at (614) 722-1746 or email at Olivia.Groves@NationwideChildrens.org

What is sepsis?

Sepsis is a potentially life threatening response to infection that can

• Happen to someone of any age
• Cause damage to the body’s organs
• Prevent a person from being able to function normally or independently
• Limit awareness and cause coma
• Cause death

 What is PRoMPT BOLUS?

Emergency department (ED) care for suspected sepsis in the US is not the same everywhere. Doctors use their judgment, but what treatment will work best is not known. The purpose of this study is to find out which of two commonly used IV fluids types given in the emergency department for sepsis is the most effective.

• Normal Saline (NS)
• Balanced fluids (including lactated Ringer’s and Plasma-Lyte)

Who will be included?

• Any child who is older than 6 months and less than 18 years of age, and
• Is suspected to have sepsis by their medical team in the emergency department

Half of the study participants will be randomly selected to receive NS and the other half will be randomly selected to receive balanced fluids. All other tests and medications will be given according to normal routines in the hospital. Any fluid that a patient needs will be given as study fluid during the first 1-2 days in the hospital. Study team members will follow patients to see which fluid worked the best.

What are the benefits?

Both NS and balanced fluids are commonly used to treat sepsis and both are FDA-approved and effective in sepsis. But, because we do not know if one fluid is better for treating sepsis, we cannot know if a particular person enrolled in the study will receive a better fluid than he or she may have otherwise received.

Based on the information we get from this study, people who have sepsis in the future may benefit from what is learned during this study.

What are the risks?

Even though fluids can be life-saving, there are risks to receiving the study fluids. But the risks of the study fluids are similar to those that a patient might have if they receive fluid treatment for their sepsis outside of this study. 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 may have higher mortality than the other.

How is enrollment different?

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.

What is EFIC?

The U.S. Food and Drug Administration (FDA) is an agency of the federal government that oversees human research protection involving medicines. The FDA has created a set of special rules, called “Exception from Informed Consent” (EFIC), that research studies in certain emergency situations to be conducted without consent. EFIC can only be used when:

• The person’s life is at risk, AND,
• The best treatment is not known, AND
• The study might help the person, AND
• It is not possible to get permission:
  • from the person because of his or her medical condition nor
  • from the person’s guardian because there is a very short amount of time required to treat the medical problem

Before researchers may do a study using EFIC, they must provide information about the study to the community and get their feedback.

Why do this study?

The best possible outcomes in patients with sepsis likely depend on timely treatment in the ED with the most effective fluids along with antibiotics and other medicines.

This study will help us to determine which of two commonly used fluids in the treatment of children with sepsis leads to the best outcomes.

What if I don't want my child to participate?

Call us (see contact information below) to request that an Opt Out bracelet be sent to you to wear with the words "PROMPT BOLUS declined." You will need to wear this bracelet at all times during the study period, or else you could be enrolled in the emergency department. If you do not participate in the study, you will receive the standard medical treatment provided for sepsis.

Where can I learn about the study?

Learn more here. If you would like to know about a community meeting near you or to get more information about the PROMPT BOLUS study, call (614) 722-6910 or email PRoMPTBOLUS@NationwideChildrens.org.