Calcium for Out-of-Hospital Cardiac Arrest (COCA)

Lars Wiuff Andersen

Status and phase: Completed; Phase 2

Conditions: Heart Arrest, Out-Of-Hospital

Treatments: Drug: Calcium Chloride; Drug: Sodium chloride 0.9%

Study type: Interventional

Funder types: Other

Identifiers

NCT04153435

00002

2019-003387-46 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 397 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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397 participants in 2 patient groups, including a placebo group

Calcium

Experimental group

Description:

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.

Treatment:

Drug: Calcium Chloride

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Sodium chloride 0.9%