Surviving PEA in Roanoke (SPEAR) Study

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCarol Bernier

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patient less than 18 years old

Known pregnancy

Duration of untreated cardiac arrest of more than 30 minutes

Traumatic cardiac arrest

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

342 Participants
are divided into 2 treatment groups
Group A: High-Calcium, High- Sodium (HCHS) groupActive comparator 1 intervention
Group B: High-Calcium, Low- Sodium (HCLS) groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Event Survival

ROSC sustained until arrival at the emergency department and transfer of care to medical staff at the receiving hospital?

Time frame
Up to 1 hour

Secondary outcomes

1

Any Return-Of-Spontaneous-Circulation (ROSC)

Did the patient achieve ROSC at any point during the resuscitation attempt?

Time frame
Through resuscitation efforts up to 1 hour after arrival to (ED) Emergency Department
2

Survival to hospital discharge

Did the patient survive to hospital discharge?

Time frame
Up to 30 days after admission to (ED) Emergency Department
3

Neurological outcome at hospital discharge

(CPC) Cerebral Performance Category Score and/or (mRS) modified Rankin Score at hospital discharge?

Time frame
Up to 30 days after admission to ED
4

Serum Electrolyte Values

All (BMP) Basic Metabolic Panel values will be collected, but there is a particular emphasis on serum sodium and calcium values.

Time frame
Up to 12 hour after admission to the (ED) Emergency Department

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Carol Bernier

Lead sponsor

Carilion Clinic

Sponsor institution

Virginia Polytechnic Institute and State University

Collaborator