Clinical trial NCT05283850: Surviving PEA in Roanoke (SPEAR) Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Cardiac Arrest
Pulseless Electrical Activity
Keywords: Crystalloid Fluids
Emergency Medical Services (EMS)
Pre-Hospital Medicine
Sodium Chloride
Calcium Chloride
Normal Saline
Half-Normal Saline
Waiver of Informed Consent
Paramedic
Electrolyte
Lead sponsor: Carilion Clinic
Sponsor class: OTHER
Collaborators: name: Virginia Polytechnic Institute and State University
First posted: 2022-03-17
Enrollment: 342
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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. Supervisors, when providing care, will universally administer 1g unblinded CaCl2 and then subsequently chose a crystalloid fluid set to use from their trucks randomly. The crystalloid will be administered as a wide open IV drip at a rate of at least 1000ml/hour, depending on gauge size, for as long as fluids are indicated for, likely resulting in a crystalloid dose of 0.5-2(L) liters. Each bag-set will have two bags of the same blinded unit to allow for treatment with up to (2L) 2 liters of fluid for a patient. Explicitly, all enrolled patients will be receiving calcium, it is only the crystalloid fluid (normal saline vs half-normal saline) that will differ. HCLS treatment was designed to be hyponatremic compared to normal saline (while both groups in this trial will be hypercalcemic compared to pure normal saline PEA therapy) in order to initiate low sodium inotropy.

The contents of the bag will be blinded to the supervisor. Neither the patient nor the supervisor will know which treatment was given thus ensuring double-blinding. Further, by randomly choosing a bag with no knowledge of its contents, the treatment will effectively be randomized. Both groups will otherwise receive current routine Advanced Cardiac Life Support and either standard post-arrest care or standard termination of care. Per Roanoke Fire-EMS, Botetourt County Department of Fire \& EMS and Salem Fire-EMS standard protocol, only patients who undergo ROSC on scene will be transported to a hospital.

Eligibility 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

Primary outcomes:
measure: Event Survival
timeFrame: Up to 1 hour
Secondary outcomes:
measure: Any Return-Of-Spontaneous-Circulation (ROSC)
timeFrame: Through resuscitation efforts up to 1 hour after arrival to (ED) Emergency Department
measure: Survival to hospital discharge
timeFrame: Up to 30 days after admission to (ED) Emergency Department
measure: Neurological outcome at hospital discharge
timeFrame: Up to 30 days after admission to ED
measure: Serum Electrolyte Values
timeFrame: Up to 12 hour after admission to the (ED) Emergency Department
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
Study officials:
affiliation: Virginia Polytechnic Institute and State University
name: Carol Bernier, DO
role: PRINCIPAL_INVESTIGATOR
References: