Study Spotlight: Surviving PEA in Roanoke (SPEAR)

When emergency medical services (EMS) respond to a call for someone whose health crisis results in pulseless electrical activity (PEA), they need to act fast. PEA is a condition where the heart has an organized rhythm, but the patient has no detectable pulse. It can result from heart attack, toxins and other conditions that decrease oxygen and blood flow.

The survival rate for patients with PEA is less than 10% with traditional crystalloid therapy. Crystalloid therapy is a routine treatment that traditionally uses normal saline and involves administering medical salt water with sodium and chloride in it. Crystalloid fluids are used to hydrate patients and maintain their blood pressure.

To improve on those outcomes, Carilion Clinic has partnered with area EMS professionals to study the potential of a new intervention option: high-calcium, low-sodium (HCLS) fluid. HCLS is another type of salt water but it uses more calcium and less sodium than normal saline. While the ingredients may be very similar, the slight difference in the ingredient ratio may have a beneficial effect on PEA hearts.

SPEAR Study

This study started in January 2021 and should take about 5 years to enroll patients. It is sponsored by the Carilion Clinic Department of Emergency Medicine and is based on the best available science provided by the Fralin Biomedical Research Institute at VTC.

“We have been upset by PEA outcomes for quite some time," said Emergency Medicine specialist Carol Bernier, DO, the study's principal investigator, "and we are optimistic that this one-of-a-kind study may finally help these patients and continue be an example of Carilion’s commitment to research.”

The research team predicts that HCLS will improve PEA survival rates—or at the very least, deliver similar outcomes as routine treatment.

Ensuring that patients are treated without delay is essential due to PEA’s rapidity and lethality. This double-blind, prospective, randomized, placebo-controlled, pre-hospital study will automatically enroll adult PEA patients treated by our partners:

• Roanoke Fire-EMS
• Botetourt County Department of Fire & EMS
• Salem Fire-EMS

Patients must be automatically enrolled in order for EMS patients, who will be nonresponsive, to be enrolled in this study.

All patient data will be stored in HIPAA-regulated Carilion and EMS software. By keeping all patient data in HIPAA-regulated software, the risk of a data breach is minimized. Patient data will further be deidentified when possible to further protect data privacy.

Regardless of which treatment they receive on site, all patients will receive the same high-quality cardiac arrest and post-cardiac arrest care by their care teams at Carilion Clinic.

Not everyone with PEA will be included in the study; certain patients will be automatically excluded:

• Patients with a durable do not resuscitate order or durable DNR, which is a written physician’s order issued to withhold cardiopulmonary resuscitation in the event of cardiac or respiratory arrest, will not be enrolled.
• Patients who are younger than 18, pregnant or imprisoned will also not be eligible for the study.
• Finally, patients with the following medical conditions will be excluded: a duration of untreated cardiac arrest of more than 30 minutes, traumatic cardiac arrest, known LVAD, rapidly fatal underlying disease and/or known or suspected digitalis toxicity.

The SPEAR study stands for Surviving PEA in Roanoke. This groundbreaking research could not be done without the Roanoke community, and in turn, we hope our research will benefit the Roanoke community. The discoveries from this trial, and our community, will forever change the future of PEA care.

The SPEAR study is one of 120 clinical trials currently under way at Carilion Clinic and our affiliated partners. Find out more at CarilionClinic.org/research.