Calcium for Out-of-Hospital Cardiac Arrest

Study Overview
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Brief Summary
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This is an investigator-initiated, multicenter, randomized, placebo-controlled, parallel group, double-blind, superiority trial of calcium during adult out-of-hospital cardiac arrest. 430 adult patients with out-of-hospital cardiac arrest receiving at least one dose of adrenaline will be enrolled. The primary outcome is sustained return of spontaneous circulation and key secondary outcomes include survival at 30 days and survival at 30 days with a favorable neurological outcome.

Official Title
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Calcium for Out-of-Hospital Cardiac Arrest - A Randomized, Double-Blind, Placebo-Controlled Trial

Conditions
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Heart Arrest, Out-Of-Hospital

Intervention / Treatment
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* Drug: Calcium Chloride
* Drug: Sodium chloride 0.9%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Out-of-hospital cardiac arrest Age ≥ 18 years Received at least one dose of adrenaline Exclusion Criteria: Traumatic cardiac arrest - including drowning and external asphyxia (e.g., hanging, strangulation, or foreign object airway obstruction) Known or strongly suspected pregnancy Prior enrollment in the trial Received adrenaline during cardiac arrest before arrival of prehospital personnel with the study drug Clinical indication for calcium administration during the cardiac arrest

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calcium<br>The intervention will consist of 5 mmol (10 mL ampoule) of calcium chloride (CaCl2) administered intravenously or intraosseously immediately after the first dose of adrenaline and again after the second dose of adrenaline. | Drug: Calcium Chloride<br>* Calcium chloride 5 mmol<br>* Other names: CaCl2;|
| Placebo Comparator: Placebo<br>The placebo will consist of 10 mL of 9 mg/mL sodium chloride (NaCl, normal saline) administered intravenously or intraosseously immediately after the first dose of adrenaline and again after the second dose of adrenaline. | Drug: Sodium chloride 0.9%<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Sustained Return of Spontaneous Circulation | Palpable pulses or other signs of circulation without a need for chest compressions lasting at least 20 minutes. | Before or after hospital arrival (up to 2 hours after the cardiac arrest) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With 30-day Survival |  | 30 days after the cardiac arrest | 
| Number of Participants With 30-day Favorable Neurological Outcome | Neurological outcome will be assessed with the modified Rankin Scale (mRS) which is a scale from 0 to 6 assessing neurological/functional outcomes after brain damage with higher scores indicating worse neurological/functional outcomes. The scale will will be dichotomized as favorable (mRS 0-3) vs. unfavorable (mRS 4-6). | 30 days after the cardiac arrest |