Trial Summary
What is the purpose of this trial?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.
Is High Calcium, Low Sodium (HCLS) Crystalloid Therapy a promising treatment for cardiac arrest?The research does not show that calcium therapy improves survival in cardiac arrest. There is no strong evidence supporting the use of calcium in these situations, so it is not considered a promising treatment.13478
What safety data exists for High Calcium Crystalloid Therapy in cardiac arrest?The safety data for High Calcium Crystalloid Therapy, including its use in cardiac arrest, indicates potential risks and limited benefits. Calcium chloride has been used since the 1920s for resuscitation in cases like asystole and electromechanical dissociation, but studies have shown dangerously elevated serum calcium levels and no significant improvement in survival rates. A systematic review found no evidence that calcium administration during cardiopulmonary resuscitation improves survival. High calcium levels can be cardiotoxic, potentially causing arrhythmias and cardiac arrest. While calcium may be beneficial in specific conditions like hyperkalemia or hypocalcemia, its routine use in cardiac arrest is not supported by current evidence.12489
What data supports the idea that High Calcium Crystalloid Therapy for Cardiac Arrest is an effective treatment?The available research shows that there is no evidence supporting the effectiveness of High Calcium Crystalloid Therapy for improving survival in cardiac arrest cases. Studies have not demonstrated significant benefits in survival rates when calcium is used during resuscitation. In fact, some studies have reported no improvement in survival compared to other treatments, like saline. Additionally, the use of calcium in certain conditions, such as hyperkalemia, lacks strong evidence and remains unclear. Therefore, the data does not support the idea that this treatment is effective for cardiac arrest.14567
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial involves emergency treatment for cardiac arrest, it is unlikely that you would need to stop any medications beforehand.
Eligibility Criteria
The SPEAR study is for patients who experience a type of cardiac arrest called PEA, where the heart's electrical activity is normal but it doesn't contract. Participants must be treated by certain EMS providers in Roanoke and not have a DNR order, known pregnancy, untreated cardiac arrest over 30 minutes, traumatic cardiac arrest, LVAD device or digitalis toxicity.Inclusion Criteria
I was unconscious and had no pulse but my heart wasn't in a common irregular rhythm.
Exclusion Criteria
I may have side effects from heart medication.
I experienced a heart stoppage for over 30 minutes without treatment.
I am under 18 years old.
Treatment Details
This trial tests if High Calcium, Low Sodium (HCLS) fluid improves survival in PEA compared to standard salt solution therapy. It's a double-blind study meaning neither the patient nor provider knows which treatment is given. Patients are randomly assigned to receive either HCLS or routine fluid therapy.
2Treatment groups
Experimental Treatment
Active Control
Group I: High-Calcium, Low- Sodium (HCLS) groupExperimental Treatment1 Intervention
Patients will receive a drip of blinded, intravenous, half-normal saline and an unblinded, intravenous, one gram bolus of calcium chloride.
Group II: High-Calcium, High- Sodium (HCHS) groupActive Control1 Intervention
Patients will receive a drip of blinded, intravenous, normal saline and an unblinded, intravenous, one gram bolus of calcium chloride.
High Calcium, Low Sodium (HCLS) Crystalloid Therapy is already approved in United States for the following indications:
🇺🇸 Approved in United States as High Calcium, Low Sodium Crystalloid Therapy for:
- Pulseless Electrical Activity (PEA) in cardiac arrest
Find a clinic near you
Research locations nearbySelect from list below to view details:
Carilion ClinicRoanoke, VA
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Who is running the clinical trial?
Carol BernierLead Sponsor
Virginia Polytechnic Institute and State UniversityCollaborator
References
Calcium: limited indications, some danger. [2013]Calcium chloride has been advocated since the 1920s for the resuscitation of asystole, electromechanical dissociation (EMD), and ventricular fibrillation. Reports of side effects and complications have been numerous. Studies of calcium assays following American Heart Association recommended dosages have shown dangerously elevated serum levels. Large retrospective clinical studies in Milwaukee and Tampa have found no evidence of improved survival with calcium chloride in asystole and EMD. A prospective randomized double-blind study comparing calcium chloride and saline controls in the Milwaukee Paramedic system for asystole and EMD using standard AHA protocols showed no statistically significant difference in resuscitation rates or long-term survival between the calcium and no-calcium groups for the rhythm of asystole. Although patients with EMD had statistically improved resuscitation rates when calcium chloride was given, only one of the patients survived to hospital discharge. Because of the low rates of resuscitation and long-term survival in patients presenting in asystole and EMD, proving that calcium chloride does not enhance survival would require large multicenter trials. However, since no controlled study has ever documented significant benefit, its routine use in asystole and EMD cannot be supported. Calcium has long been used in medical treatment of hypocalcemic and hyperkalemic states and should be administered in moribund patients who have the proper clinical history and clinical signs of hypocalcemia.
Verapamil reverses calcium cardiotoxicity. [2019]High circulating concentrations of calcium are toxic to the heart and may cause cardiac arrhythmias and arrest. To investigate the therapeutic use of calcium antagonists in hypercalcemia, we evaluated the efficacy of verapamil hydrochloride and magnesium chloride in the treatment of experimental calcium-induced cardiac arrest in laboratory rats. Verapamil rapidly reversed the experimental calcium-induced arrest and improved survival (83% survival versus 0% in controls). Magnesium failed to reverse this toxic event. We conclude from these experimental studies that verapamil may be useful in the treatment of hypercalcemic cardiac toxicity.
An intracellular-like cardioplegic solution. Its enhancement of myocardial protection. [2019]We sought to determine the relative protective effects of an intracellular-like, calcium-bearing, crystalloid solution (ICS) and a calcium-free, extracellular-like solution (ECS). Both solutions were similar in concentrations of potassium ions (25 to 26 mEq/L), in pH (7.7 to 7.8), and in osmolarity (340 to 360 mOsm/L). Normothermia was used to obviate masking the true effects of the solutions with the independent effects of hypothermia. Fifty-seven dogs were placed on cardiopulmonary bypass and had global myocardial ischemia for one hour. Continuous infusions and bolus injections into the aortic root of control solutions (n = 24), ECS (n = 15), and ICS (n = 16) were used. Two-hour postischemic ventricular performance was superior for ICS in comparison with ECS or control solutions regardless of administration mode. The multidose mode gave improved results with control and ECS groups. The use of an ICS yields improved postischemic performance in normothermic dog hearts.
Calcium administration during cardiac arrest: a systematic review. [2018]This topic highlights the results of the literature review on calcium therapy during cardiac arrest and cardiopulmonary resuscitation according to the Patient/population, Intervention, Comparator, Outcome structure. Eligible studies were assigned to one of the five levels of evidence. Their quality was rated as either good, fair, or poor and then classified as supportive, neutral, or opposing according to the outcome benefits. Among the 48 articles retrieved, 10 articles fulfilled all the criteria for analysis for the Guidelines preparation. There is no evidence that the administration of calcium during cardiopulmonary resuscitation improves survival from cardiac arrest irrespective of the presenting rhythm. In the setting of hyperkalemia, calcium channel blocker intoxication, hypocalcemia, and hypermagnesemia, the role of calcium remains unclear because of the limited amount of evidence. The main limitation is the scarcity of data, most of which relate to anoxic cardiac arrest, accounting for no more than 25% of the causes of cardiac arrest in humans.
The Use of Low-Calcium Hemodialysis in the Treatment of Hypercalcemic Crisis. [2019]We reviewed the results of low-calcium hemodialysis (LCHD; 1.25 mmol/L) in the treatment of 42 cases admitting with hypercalcemic crisis.
The effect of calcium gluconate in the treatment of hyperkalemia. [2022]Intravenous (IV) calcium salts are routinely recommended as a cardio-protective therapy in the emergency treatment of severe hyperkalemia. However, this recommendation is supported by a low level of evidence and is anecdotal. The aim of this study is to determine the effectiveness of IV Calcium (Ca) gluconate in the treatment of hyperkalemia.
Effect of calcium vs. placebo on long-term outcomes in patients with out-of-hospital cardiac arrest. [2022]The Calcium for Out-of-hospital Cardiac Arrest (COCA) trial was a randomized, placebo-controlled, double-blind trial of calcium for out-of-hospital cardiac arrest. The primary and secondary outcomes have been reported previously. This article describes the long-term outcomes of the trial.
Effect of calcium in patients with pulseless electrical activity and electrocardiographic characteristics potentially associated with hyperkalemia and ischemia-sub-study of the Calcium for Out-of-hospital Cardiac Arrest (COCA) trial. [2023]The Calcium for Out-of-hospital Cardiac Arrest (COCA) trial was recently conducted and published. This pre-planned sub-study evaluated the effect of calcium in patients with pulseless electrical activity (PEA) including subgroup analyses based on electrocardiographic characteristics potentially associated with hyperkalemia and ischemia.
The amount of calcium in calcium chloride - Is there a need to clarify emergency treatment of hyperkalaemia algorithm? [2023]European Resuscitation Council (ERC) and American Heart Association (AHA) guidelines emphasize a rapid administration of calcium chloride (10 ml 10 % CaCl2) to protect the myocardium in the hyperkalaemia algorithm. However, calcium chloride preparations available in European markets vary from country to country. In our opinion, the drug dose recommended in the guidelines should not raise questions about the volume and amount of calcium in the intravenous supply and should be unambiguous to minimize the risk of error. Calcium dose should be given in terms of mmol/L or mEq or mg of calcium ions.