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
Carol Bernier
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.
Description
Pursuant to a Waiver of Informed Consent, this investigation will automatically enroll all eligible PEA patients treated by Roanoke Fire-EMS, Botetourt County Department of Fire \& EMS and/or Salem Fire-EMS systems. Once patients are enrolled, they will be de-facto randomized into one of two groups: control High Calcium-High Sodium (HCHS) or interventional High Calcium-Low Sodium (HCLS). Supervisors will have on their trucks, numbered-but-otherwise-blinded bags of half-normal saline or normal saline solution. The bags will be numbered, recorded and randomized by this study's investigators. Su…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 * Rap…
Interventions
- DrugHigh Calcium, Low Sodium (HCLS) Crystalloid Therapy
Half-normal saline IV drip and 1g IV bolus Calcium Chloride.
- DrugHigh Calcium, High Sodium (HCHS) Crystalloid Therapy
Normal saline IV drip and 1g IV bolus Calcium Chloride.
Location
- Carilion ClinicRoanoke, Virginia