Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
NCT05283850

Surviving PEA in Roanoke (SPEAR) Study

Led by Carol Bernier · Updated on 2022-03-17

342

Participants Needed

1

Research Sites

258 weeks

Total Duration

On this page

Sponsors

C

Carol Bernier

Lead Sponsor

V

Virginia Polytechnic Institute and State University

Collaborating Sponsor

AI-Summary

What this Trial Is About

The Carilion Clinic and Virginia Tech Carilion School of Medicine, in conjunction with Roanoke Fire-EMS, Botetourt County Department of Fire \& EMS and Salem Fire-EMS, are studying the outcomes of patients experiencing Pulseless Electrical Activity (PEA). PEA refers to a type of cardiac arrest in which there is normal electrical activity in the heart however the heart still fails to contract to generate a pulse. Without heart contractions, which normally generates a pulse, the brain and other important organs fail to receive blood and oxygen. Unfortunately, the majority (97.3%) of patients that experience this rhythm do not survive and most don't even make it to the hospital. This study is trying to determine if the administration of a High Calcium, Low Sodium (HCLS) fluid in pre-hospital care will improve the chances of survival. Generally, a sodium (salt) solution is provided to patients experiencing cardiac arrest. Studies have shown that lower sodium and higher calcium content may activate certain parts of the heart cells required to generate a pulse under PEA conditions. This study is a double-blind, prospective, clinical trial. PEA patients will randomly receive either routine fluid therapy (salt solution) or a HCLS solution. While HCLS solution is not the standard fluid used by EMS providers responding to PEA, it is composed of FDA approved components and is occasionally used by EMS providers at their discretion in treating PEA. It is predicted that HCLS will either improve PEA survival or deliver similar outcomes as routine treatment. All patients will receive standard, high quality cardiac arrest and post-cardiac arrest care regardless of assigned treatment group.

CONDITIONS

Official Title

Surviving PEA in Roanoke (SPEAR) Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients presenting with Pulseless Electrical Activity (PEA) during treatment by Roanoke Fire-EMS, Botetourt County Department of Fire & EMS, or Salem Fire-EMS
  • PEA defined as unconsciousness, no carotid pulse, and non-ventricular tachycardia/fibrillation electrical activity
Not Eligible

You will not qualify if you...

  • Patients under 18 years old
  • Known pregnancy
  • Cardiac arrest untreated for more than 30 minutes
  • Traumatic cardiac arrest
  • Presence of left ventricular assist device (LVAD)
  • Rapidly fatal underlying disease
  • Known or suspected digitalis toxicity
  • Presentation of a do-not-resuscitate (DNR) order or medical jewelry before treatment
  • Prisoners or individuals unable to give voluntary consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

Carilion Clinic

Roanoke, Virginia, United States, 24014

Actively Recruiting

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Research Team

C

Cara Spivy, MS

CONTACT

W

William Reis, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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