Current Environment:

Study Details

Why?

Very low blood pressure can be a medical emergency, and if not treated quickly can be life-threatening or cause harm to vital organs like the heart, brain, and kidneys. In order to find the best possible treatment for very low blood pressure, studies need to be done to give doctors information on what dose of epinephrine works best. Many different doses work well, but we need your help to find the best dose.

What we know

From previous studies at Boston Children's Hospital, we know that our ICU clinicians use many different initial doses of epinephrine for very low blood pressure. Most often, doctors use doses between 0.5 mcg/kg to 1 mcg/kg as the initial dose and then adjust later doses based on the response of the blood pressure. Unfortunately, the existing information is not able to tell us what dose is best, but initial doses between 0.5 to 1 mcg/kg seemed to benefit patients similarly.

Who?

Patients hospitalized in the MICU (11 South) or MSICU (7 South) who are 25 years or younger are eligible to participate if their blood pressure becomes dangerously low and the ICU team thinks epinephrine will help.

How?

If a patient’s ICU team determines that they need epinephrine for life-threatening low blood pressure, the patient may be enrolled in the EPI Dose Study immediately. Patients who need epinephrine will have a 50:50 chance of receiving EITHER 0.5 mcg/kg OR 1 mcg/kg as the initial dose. The effects on blood pressure and other patient information will be collected from the chart. No other interventions or participation is required.

EPI Dose Trial flowchart 

Safety

It is important to understand that patients enrolled in the EPI Dose Trial would have received epinephrine regardless of being in the study or not; the only difference is the chance of getting one dose or the other as opposed to your doctor choosing which dose to give. Also, the study only affects the first dose of epinephrine needed; if more epinephrine is needed, your doctor will decide how much to give. If your doctor is not satisfied with the increase in blood pressure after the first dose, he/she may give as much additional medication or adjust future doses as necessary.

Your child’s safety will continue to be the top priority.

For more detailed information on the EPI Dose Study, click here.

Possible Risk/Side Effect

How often has it occurred?

How serious is it?

Can it be corrected?

Blood pressure does not go up enough.

Common with either dose of epinephrine.

However, we do not know if it is more common with one dose versus the other.

If prolonged, low blood pressure can damage vital organs including the brain and heart and can sometimes cause death.

Often the low blood pressure can be corrected with higher doses of epinephrine or other treatments as part of intensive care. However, if there is organ damage, these effects may be irreversible.

Blood pressure goes up too high.

Occasional with either dose of epinephrine.

However, we do not know if it is more common with one dose versus the other.

For most children and young adults, temporary blood pressure does not cause damage. However, extremely high blood pressure even for a short period could cause organ damage including bleeding in the brain and can sometimes cause death.

Yes. High blood pressure after epinephrine usually goes away on its own within minutes without any apparent long-term effects. However, if there is organ damage or bleeding in the brain from extremely high blood pressure, these effects may be irreversible.

Exception From Informed Consent and the EPI Dose Study

Because very low blood pressure can be an emergency, the ICU team has to act very quickly to give treatments, including epinephrine. For many studies, we discuss participation with families beforehand to get their consent; however, in the case of an emergency, like very low blood pressure, this is often not possible. In these cases, the FDA allows for “Exception From Informed Consent” in which the patient participates in the study, and then the study is discussed with the family afterward.

In these cases, we do our best to make families aware of the study beforehand and give them the option to “opt out”, if they do not want their child to participate. In the extremely rare event that the ICU team believes there is sufficient time during the emergency, a research team member may approach the family to provide a detailed overview of the study to obtain informed consent. To meet requirements for use of Exception From Informed Consent in the EPI Dose Study, we have provided brochures to every family upon admission to the ICU, attempted to visit each family in person or by phone, and created this website.

EPI Dose Trial detailed flowchart