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Surviving PEA in Roanoke (SPEAR) Study

RecruitingPhase 2, Phase 3Ages 18 Years - anyAllCarol Bernier
NCT05283850 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 patie

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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
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What it tests

  • High Calcium, Low Sodium (HCLS) Crystalloid Therapy
  • High Calcium, High Sodium (HCHS) Crystalloid Therapy
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Where

1 site
Carilion Clinic
Roanoke, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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