Calcium for Out-of-Hospital Cardiac Arrest

Lars Wiuff Andersen397 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

397

Conditions

Heart Arrest, Out-Of-Hospital

Interventions

Calcium ChlorideDRUG

Calcium chloride 5 mmol

Sodium chloride 0.9%DRUG

Placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Prehospital Emergency Medical Services

Aarhus N, Central Jutland, Denmark

Outcomes

Primary Outcomes

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.

Time frame: Before or after hospital arrival (up to 2 hours after the cardiac arrest)

Secondary Outcomes

Number of Participants With 30-day Survival

Time frame: 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).

Time frame: 30 days after the cardiac arrest

Data from ClinicalTrials.gov

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