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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Virginia
Carilion Clinic
RECRUITING
Roanoke
Contact Information
Primary
Cara Spivy, MS
crspivey@carilionclinic.org
540-676-7965
Backup
William Reis, MS
wrreis@carilionclinic.org
Time Frame
Start Date: 2022-02-16
Estimated Completion Date: 2027-02
Participants
Target number of participants: 342
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Virginia Polytechnic Institute and State University
Leads: Carol Bernier

This content was sourced from clinicaltrials.gov