High Calcium Crystalloid Therapy for Cardiac Arrest (SPEAR Trial)

Phase 2 & 3

Recruiting

Led By Carol Bernier, DO

Research Sponsored by Carol Bernier

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Be older than 18 years old

Must not have

Known or suspected digitalis toxicity

Duration of untreated cardiac arrest of more than 30 minutes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through resuscitation efforts up to 1 hour after arrival to (ed) emergency department

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying whether a high calcium, low sodium fluid given to patients with pulseless electrical activity (PEA) in pre-hospital care will improve the chances of survival.

Who is the study for?

The SPEAR study is for patients who experience a type of cardiac arrest called PEA, where the heart's electrical activity is normal but it doesn't contract. Participants must be treated by certain EMS providers in Roanoke and not have a DNR order, known pregnancy, untreated cardiac arrest over 30 minutes, traumatic cardiac arrest, LVAD device or digitalis toxicity.

What is being tested?

This trial tests if High Calcium, Low Sodium (HCLS) fluid improves survival in PEA compared to standard salt solution therapy. It's a double-blind study meaning neither the patient nor provider knows which treatment is given. Patients are randomly assigned to receive either HCLS or routine fluid therapy.

What are the potential side effects?

Since both fluids used in this trial are based on FDA approved components and one is already standard care, side effects may be minimal and similar to those experienced with typical IV fluids such as electrolyte imbalances or reactions at the infusion site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was unconscious and had no pulse but my heart wasn't in a common irregular rhythm.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I may have side effects from heart medication.

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I experienced a heart stoppage for over 30 minutes without treatment.

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I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through resuscitation efforts up to 1 hour after arrival to (ed) emergency department

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through resuscitation efforts up to 1 hour after arrival to (ed) emergency department

This trial's timeline: 3 weeks for screening, Varies for treatment, and through resuscitation efforts up to 1 hour after arrival to (ed) emergency department for reporting.