Calcium for Out-of-Hospital Cardiac Arrest

Overview

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.

Full Title of Study: “Calcium for Out-of-Hospital Cardiac Arrest – A Randomized, Double-Blind, Placebo-Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 15, 2021

Interventions

  • Drug: Calcium Chloride
    • Calcium chloride 5 mmol
  • Drug: Sodium chloride 0.9%
    • Placebo

Arms, Groups and Cohorts

  • Experimental: Calcium
    • 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.
  • Placebo Comparator: Placebo
    • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Number of Participants With 30-day Survival
    • Time Frame: 30 days after the cardiac arrest
  • Number of Participants With 30-day Favorable Neurological Outcome
    • Time Frame: 30 days after the cardiac arrest
    • 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).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Lars Wiuff Andersen
  • Collaborator
    • Central Denmark Region
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Lars Wiuff Andersen, Associate Professor – Aarhus University Hospital
  • Overall Official(s)
    • Lars W Andersen, Principal Investigator, Aarhus University Hospital

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