RECRUITING

Surviving PEA in Roanoke (SPEAR) Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Prospective, Pre-Hospital Comparison of Normal Saline Versus Half-Normal Saline, After Universal Calcium Chloride Administration, to Improve Outcomes in Pulseless Electrical Activity Patients

Quick Facts

Study Start:2022-02-16
Study Completion:2027-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05283850

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  1. * Patient less than 18 years old
  2. * Known pregnancy
  3. * Duration of untreated cardiac arrest of more than 30 minutes
  4. * Traumatic cardiac arrest
  5. * Known (LVAD) Left Ventricular Assist Device
  6. * Rapidly fatal underlying disease
  7. * Known or suspected digitalis toxicity
  8. * 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
  9. * Prisoners and other populations with involuntary consent

Contacts and Locations

Study Contact

Cara Spivy, MS
CONTACT
540-676-7965
crspivey@carilionclinic.org
William Reis, MS
CONTACT
wrreis@carilionclinic.org

Principal Investigator

Carol Bernier, DO
PRINCIPAL_INVESTIGATOR
Virginia Polytechnic Institute and State University

Study Locations (Sites)

Carilion Clinic
Roanoke, Virginia, 24014
United States

Collaborators and Investigators

Sponsor: Carol Bernier

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-16
Study Completion Date2027-02

Study Record Updates

Study Start Date2022-02-16
Study Completion Date2027-02

Terms related to this study

Keywords Provided by Researchers

  • Crystalloid Fluids
  • Emergency Medical Services (EMS)
  • Pre-Hospital Medicine
  • Sodium Chloride
  • Calcium Chloride
  • Normal Saline
  • Half-Normal Saline
  • Waiver of Informed Consent
  • Paramedic
  • Electrolyte

Additional Relevant MeSH Terms

  • Cardiac Arrest
  • Pulseless Electrical Activity