ClinConnect ClinConnect Logo
Search / Trial NCT05283850

Surviving PEA in Roanoke (SPEAR) Study

Launched by CAROL BERNIER · Mar 8, 2022

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

Crystalloid Fluids Emergency Medical Services (Ems) Pre Hospital Medicine Sodium Chloride Calcium Chloride Normal Saline Half Normal Saline Waiver Of Informed Consent Paramedic Electrolyte

ClinConnect Summary

The SPEAR Study is a clinical trial being conducted by the Carilion Clinic and Virginia Tech Carilion School of Medicine, along with local fire and emergency services, to investigate how to better treat patients experiencing a specific type of cardiac arrest called Pulseless Electrical Activity (PEA). In PEA, the heart has normal electrical activity but fails to pump blood, which can lead to severe consequences since the brain and other vital organs don’t get the blood and oxygen they need. Unfortunately, most patients with PEA do not survive. This study aims to see if using a special fluid with high calcium and low sodium (HCLS) can improve survival rates compared to the usual salt solution that is typically given.

Patients aged 18 and older who experience PEA while being treated by the involved emergency services may be eligible to participate in the study. Participants will be randomly assigned to receive either the new HCLS fluid or the standard treatment, but all will still receive high-quality care for their cardiac arrest. It’s important to note that certain individuals, such as those with specific medical conditions or a Do Not Resuscitate order, will not be included in the trial. Overall, this study hopes to find a better way to help patients during a critical time when every moment counts.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • All patients who present with PEA at any time during the patients' treatment by Roanoke Fire-EMS, Botetourt County Department of Fire \& EMS and/or Salem Fire-EMS. This study defines a PEA presentation as any patient who is unconscious, presenting without a carotid pulse and with non-(VT/VF) ventricular tachycardia/ventricular fibrillation electrical activity.
  • Exclusion Criteria:
  • Patient less than 18 years old
  • Known pregnancy
  • Duration of untreated cardiac arrest of more than 30 minutes
  • Traumatic cardiac arrest
  • Known (LVAD) Left Ventricular Assist Device
  • Rapidly fatal underlying disease
  • Known or suspected digitalis toxicity
  • A physical, durable (DNR) Do Not Resuscitate (or durable DNR medical jewelry) presented to EMS before treatment with asserting a preference not to be enrolled
  • Prisoners and other populations with involuntary consent

About Carol Bernier

Carol Bernier is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes. With a focus on innovative therapies and evidence-based practices, Ms. Bernier leads initiatives that facilitate the design, oversight, and execution of clinical trials across various therapeutic areas. Her extensive experience in trial management and regulatory compliance ensures that studies are conducted with the highest standards of ethics and scientific rigor. Passionate about collaboration, she fosters partnerships with healthcare professionals, research institutions, and patient advocacy groups to drive successful trial outcomes and contribute to the development of new treatment options.

Locations

Roanoke, Virginia, United States

Patients applied

0 patients applied

Trial Officials

Carol Bernier, DO

Principal Investigator

Virginia Polytechnic Institute and State University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Similar Trials