Calcium for Out-of-Hospital Cardiac Arrest

Heart Arrest, Out-Of-Hospital Clinical Trial

— COCA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04153435
• Other study ID #: 00002
• Secondary ID: 2019-003387-46
• Status: Completed
• Phase: Phase 2
• Start date: January 20, 2020
• Est. completion date: April 15, 2022

Study information

• Verified date: July 2022
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 397
• Est. completion date: April 15, 2022
• Est. primary completion date: April 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Arrest
• Heart Arrest, Out-Of-Hospital
• Out-of-Hospital Cardiac Arrest

Intervention

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

Locations

Country	Name	City	State
Denmark	Prehospital Emergency Medical Services	Aarhus N	Central Denmark Region

Sponsors (3)

Lead Sponsor	Collaborator
Lars Wiuff Andersen	Central Denmark Region, University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants With 30-day Survival		30 days after the cardiac arrest
Secondary	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

External Links

•   Trial website