Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
342 participants
INTERVENTIONAL
2022-02-16
2027-02-28
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
High Calcium, High Sodium (HCHS) Crystalloid Therapy
Normal saline IV drip and 1g IV bolus Calcium Chloride.
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.
High Calcium, Low Sodium (HCLS) Crystalloid Therapy
Half-normal saline IV drip and 1g IV bolus Calcium Chloride.
Interventions
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High Calcium, Low Sodium (HCLS) Crystalloid Therapy
Half-normal saline IV drip and 1g IV bolus Calcium Chloride.
High Calcium, High Sodium (HCHS) Crystalloid Therapy
Normal saline IV drip and 1g IV bolus Calcium Chloride.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Virginia Polytechnic Institute and State University
OTHER
Carol Bernier
OTHER
Responsible Party
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Carol Bernier
Assistant Professor of Emergency Medicine
Principal Investigators
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Carol Bernier, DO
Role: PRINCIPAL_INVESTIGATOR
Virginia Polytechnic Institute and State University
Locations
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Carilion Clinic
Roanoke, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB-19-488
Identifier Type: -
Identifier Source: org_study_id
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