Cardiac ArrestPhase 2/3SPEARNCT05283850
Surviving PEA in Roanoke (SPEAR) Study
A Phase 2/3 study testing High Calcium, Low Sodium (HCLS) Crystalloid Therapy and High Calcium, High Sodium (HCHS) Crystalloid Therapy in people with Cardiac Arrest and Pulseless Electrical Activity, run by Carol Bernier at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Pulseless Electrical Activity
- What is being tested?
- High Calcium, Low Sodium (HCLS) Crystalloid Therapy and High Calcium, High Sodium (HCHS) Crystalloid Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 342 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2022to Feb 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
William Reis, MS contact
United States1 site, 1 recruiting
- Recruiting
Carilion Clinic
Roanoke, Virginia, 24014
Carol Bernier, DO, 540-293-6352, cabernier@carilionclinic.org
About this 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
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.
Read the 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.
- Conditions
- Cardiac Arrest, Pulseless Electrical Activity
- Being tested
- High Calcium, Low Sodium (HCLS) Crystalloid Therapy, High Calcium, High Sodium (HCHS) Crystalloid Therapy
- 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
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Calcium, Low Sodium (HCLS) Crystalloid TherapyDrug
Also called (NDC) National Drug Code NDC 0264-7800-00 and NDC 0409-4928-11
Half-normal saline IV drip and 1g IV bolus Calcium Chloride.
High Calcium, High Sodium (HCHS) Crystalloid TherapyDrug
Also called NDC NDC 0264-7802-00 and NDC 0409-4928-11
Normal saline IV drip and 1g IV bolus Calcium Chloride.
| Study group | Role | What they receive |
|---|---|---|
| High-Calcium, High- Sodium (HCHS) group | Active comparator | Patients will receive a drip of blinded, intravenous, normal saline and an unblinded, intravenous, one gram bolus of calcium chloride. Receives: Drug: High Calcium, High Sodium (HCHS) Crystalloid Therapy |
| High-Calcium, Low- Sodium (HCLS) group | Experimental | Patients will receive a drip of blinded, intravenous, half-normal saline and an unblinded, intravenous, one gram bolus of calcium chloride. Receives: Drug: High Calcium, Low Sodium (HCLS) Crystalloid Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event Survival
ROSC sustained until arrival at the emergency department and transfer of care to medical staff at the receiving hospital?
Measured: Up to 1 hour
Secondary outcomes (4)
Any Return-Of-Spontaneous-Circulation (ROSC)
Did the patient achieve ROSC at any point during the resuscitation attempt?
Measured: Through resuscitation efforts up to 1 hour after arrival to (ED) Emergency Department
Survival to hospital discharge
Did the patient survive to hospital discharge?
Measured: Up to 30 days after admission to (ED) Emergency Department
Neurological outcome at hospital discharge
(CPC) Cerebral Performance Category Score and/or (mRS) modified Rankin Score at hospital discharge?
Measured: Up to 30 days after admission to ED
Serum Electrolyte Values
All (BMP) Basic Metabolic Panel values will be collected, but there is a particular emphasis on serum sodium and calcium values.
Measured: Up to 12 hour after admission to the (ED) Emergency Department
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start16 Feb 2022
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 342 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carol Bernier
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University
- Responsible party
- Sponsor-investigator, Carol Bernier, Carilion Clinic
- Investigators
- Carol Bernier, DO, Principal investigator, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283850
- Sponsor's protocol ID
- IRB-19-488
- Acronym
- SPEAR
- Status last verified
- Mar 2022
- First submitted
- 20 Feb 2022
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Unidentified data could be arranged to be shared with researchers who specifically request it, but this study is not currently (IRB) Institutional Review Board approved to do so.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05283850
- Acronym / sponsor ID
- SPEAR / IRB-19-488
- 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
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 342 participants (estimated)
- Lead sponsor
- Carol BernierUniversity, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University
- Study start
- 16 Feb 2022 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Calcium, High- Sodium (HCHS) group | Active comparator | Drug: High Calcium, High Sodium (HCHS) Crystalloid TherapyPatients will receive a drip of blinded, intravenous, normal saline and an unblinded, intravenous, one gram bolus of calcium chloride. |
| High-Calcium, Low- Sodium (HCLS) group | Experimental | Drug: High Calcium, Low Sodium (HCLS) Crystalloid TherapyPatients will receive a drip of blinded, intravenous, half-normal saline and an unblinded, intravenous, one gram bolus of calcium chloride. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Calcium, Low Sodium (HCLS) Crystalloid TherapyAlso: (NDC) National Drug Code NDC 0264-7800-00 and NDC 0409-4928-11Half-normal saline IV drip and 1g IV bolus Calcium Chloride. | Drug | High-Calcium, Low- Sodium (HCLS) group |
| High Calcium, High Sodium (HCHS) Crystalloid TherapyAlso: NDC NDC 0264-7802-00 and NDC 0409-4928-11Normal saline IV drip and 1g IV bolus Calcium Chloride. | Drug | High-Calcium, High- Sodium (HCHS) group |
Primary outcome
Event Survival
Time frame: Up to 1 hour
ROSC sustained until arrival at the emergency department and transfer of care to medical staff at the receiving hospital?
4 secondary outcomes
Any Return-Of-Spontaneous-Circulation (ROSC)
Time frame: Through resuscitation efforts up to 1 hour after arrival to (ED) Emergency Department
Survival to hospital discharge
Time frame: Up to 30 days after admission to (ED) Emergency Department
Neurological outcome at hospital discharge
Time frame: Up to 30 days after admission to ED
Serum Electrolyte Values
Time frame: Up to 12 hour after admission to the (ED) Emergency Department
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Individual participant dataSharing planned: No. Unidentified data could be arranged to be shared with researchers who specifically request it, but this study is not currently (IRB) Institutional Review Board approved to do so.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William Reis, MS contact
Carol Bernier, DO principal investigator
Virginia Polytechnic Institute and State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing High Calcium, Low Sodium (HCLS) Crystalloid Therapy and High Calcium, High Sodium (HCHS) Crystalloid Therapy in people with Cardiac Arrest and Pulseless Electrical Activity, run by Carol Bernier at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cara Spivy, MS (540-676-7965, crspivey@carilionclinic.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event Survival (time frame: Up to 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022.