Improving survival rates for cardiac arrest patients with Pulseless Electrical Activity
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
This study is testing if a special type of fluid with low sodium can help improve survival rates for patients who have a cardiac arrest with pulseless electrical activity.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 342 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Carilion Clinic Academic / other |
| Locations | 1 site (Roanoke, Virginia) |
| Trial ID | NCT05283850 on ClinicalTrials.gov |
What this trial studies
This study investigates the outcomes of patients experiencing Pulseless Electrical Activity (PEA) during cardiac arrest, focusing on the effectiveness of a High Calcium, Low Sodium (HCLS) fluid compared to a High Calcium, High Sodium (HCHS) fluid in pre-hospital care. Conducted by the Carilion Clinic and Virginia Tech Carilion School of Medicine, the study will automatically enroll eligible PEA patients treated by local emergency medical services. Patients will be randomized into two groups to receive either HCLS or HCHS fluids, with both groups receiving calcium. The goal is to determine if the HCLS fluid improves survival chances for these patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults presenting with PEA during treatment by participating emergency medical services.
Not a fit: Patients under 18 years old, those with traumatic cardiac arrest, or those with a Do Not Resuscitate order may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly increase survival rates for patients experiencing PEA during cardiac arrest.
How similar studies have performed: While studies on fluid administration in cardiac arrest have been conducted, the specific approach of using HCLS fluid in PEA patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Roanoke, Virginia
- Carilion Clinic — Roanoke, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Carol Bernier, DO — Virginia Polytechnic Institute and State University
- Study coordinator: Cara Spivy, MS
- Email: crspivey@carilionclinic.org
- Phone: 540-676-7965
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.