Surviving PEA in Roanoke (SPEAR) Study

Summary

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

• Cardiac Arrest
• Pulseless Electrical Activity

Interventions

DRUG

High Calcium, Low Sodium (HCLS) Crystalloid Therapy

Half-normal saline IV drip and 1g IV bolus Calcium Chloride.

DRUG

High Calcium, High Sodium (HCHS) Crystalloid Therapy

Normal saline IV drip and 1g IV bolus Calcium Chloride.

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University

  collaborator OTHER

• Carol Bernier

  lead OTHER

Principal Investigators

• Carol Bernier, DO · Virginia Polytechnic Institute and State University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-02-16

Primary Completion

2027-02-28

Completion

2027-02-28

FDA Drug

Yes

Countries

• United States

Study Locations