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Completed

NCT Number: NCT04153435

Calcium for Out-of-Hospital Cardiac Arrest

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.

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Key information

Conditions

Heart Arrest, Out-Of-Hospital Cardiovascular Diseases Heart Arrest Heart Diseases Out-of-Hospital Cardiac Arrest

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Prehospital Emergency Medical Services

Aarhus N, Central Jutland, 8200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Calcium chloride

Drug

Calcium chloride 5 mmol

Other names: CaCl2

Sodium chloride 0.9%

Drug

Placebo

Primary outcomes

  1. 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 outcomes

  1. Number of Participants With 30-day Survival

    Time frame: 30 days after the cardiac arrest

  2. 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).

Sponsors and collaborators

Lead sponsor

Lars Wiuff Andersen

Other

Collaborators

  • Central Denmark Region
  • University of Aarhus

Registry information

Official study title

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

Acronym: COCA

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Nov 6, 2019
Registry last updated
Jul 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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