Surviving PEA in Roanoke (SPEAR) Study
SPEAR
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
1 other identifier
interventional
342
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2022
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 16, 2022
CompletedFirst Submitted
Initial submission to the registry
February 20, 2022
CompletedFirst Posted
Study publicly available on registry
March 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
March 17, 2022
March 1, 2022
5 years
February 20, 2022
March 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Event Survival
ROSC sustained until arrival at the emergency department and transfer of care to medical staff at the receiving hospital?
Up to 1 hour
Secondary Outcomes (4)
Any Return-Of-Spontaneous-Circulation (ROSC)
Through resuscitation efforts up to 1 hour after arrival to (ED) Emergency Department
Survival to hospital discharge
Up to 30 days after admission to (ED) Emergency Department
Neurological outcome at hospital discharge
Up to 30 days after admission to ED
Serum Electrolyte Values
Up to 12 hour after admission to the (ED) Emergency Department
Study Arms (2)
High-Calcium, High- Sodium (HCHS) group
ACTIVE COMPARATORPatients will receive a drip of blinded, intravenous, normal saline and an unblinded, intravenous, one gram bolus of calcium chloride.
High-Calcium, Low- Sodium (HCLS) group
EXPERIMENTALPatients will receive a drip of blinded, intravenous, half-normal saline and an unblinded, intravenous, one gram bolus of calcium chloride.
Interventions
Half-normal saline IV drip and 1g IV bolus Calcium Chloride.
Normal saline IV drip and 1g IV bolus Calcium Chloride.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Carol Bernierlead
- Virginia Polytechnic Institute and State Universitycollaborator
Study Sites (1)
Carilion Clinic
Roanoke, Virginia, 24014, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carol Bernier, DO
Virginia Polytechnic Institute and State University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Patients, being intrinsically unconscious from PEA, will be blinded to the intervention. EMS Supervisors, in the pre-hospital setting, will administer an opaque bag of fluids with only a bag number on it, ensuring that they are blinded to the intervention. Hospital providers/outcomes assessors will know that patients were enrolled in a study and they will only know which bag number was used. The investigator will have the capacity to unblind bag numbers, but the investigator will not be the provider or outcomes assessor for patients due to the emergent nature of PEA.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor of Emergency Medicine
Study Record Dates
First Submitted
February 20, 2022
First Posted
March 17, 2022
Study Start
February 16, 2022
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2027
Last Updated
March 17, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share
Unidentified data could be arranged to be shared with researchers who specifically request it, but this study is not currently (IRB) Institutional Review Board approved to do so.