Surviving PEA in Roanoke (SPEAR) Study

Part of paid clinical trials in Roanoke, Virginia.

Sponsor
Carol Bernier
Study ID
NCT05283850
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Cardiac Arrest
  • Pulseless Electrical Activity

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • High Calcium, Low Sodium (HCLS) Crystalloid Therapy — DRUG
    Half-normal saline IV drip and 1g IV bolus Calcium Chloride.
  • High Calcium, High Sodium (HCHS) Crystalloid Therapy — DRUG
    Normal saline IV drip and 1g IV bolus Calcium Chloride.

Study Details

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.

Key Dates

Start date
Feb 16, 2022
Status verified
Mar 2022
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
342 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: High-Calcium, High- Sodium (HCHS) group
    Patients will receive a drip of blinded, intravenous, normal saline and an unblinded, intravenous, one gram bolus of calcium chloride.
  • Experimental: High-Calcium, Low- Sodium (HCLS) group
    Patients will receive a drip of blinded, intravenous, half-normal saline and an unblinded, intravenous, one gram bolus of calcium chloride.

Primary Outcome Measure

Event Survival [ Time Frame: Up to 1 hour ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Carilion ClinicRoanokeVirginia24014
Carol Bernier, DO
[email protected]
540-293-6352

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By research site
Carilion Clinic· Roanoke, VA

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