Calcium for Out-of-Hospital Cardiac Arrest

Phase 2

Completed

• Conditions: Heart Arrest, Out-Of-Hospital
• Interventions: Drug: Sodium chloride 0.9%; Drug: Calcium Chloride

• Registration Number: NCT04153435
• Lead Sponsor: Lars Wiuff Andersen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-03
• Study First Submitted QC: 2019-11-05
• Study First Posted: 2019-11-06
• Study Start: 2020-01-20
• Primary Completion: 2021-04-15
• Results First Submitted: 2022-01-11
• Results First Submitted QC: 2022-01-11
• Results First Posted: 2022-02-25
• Study Completion: 2022-04-15
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 397

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Sodium chloride 0.9%	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.
Calcium	Calcium Chloride	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Sustained Return of Spontaneous Circulation	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 Outcome Measures

Name	Time	Method
Number of Participants With 30-day Survival	30 days after the cardiac arrest
Number of Participants With 30-day Favorable Neurological Outcome	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).

Trial Locations

Locations (1)

Prehospital Emergency Medical Services; 🇩🇰 Aarhus N, Central Denmark Region, Denmark