Phase 2
N=397
Calcium for Out-of-Hospital Cardiac Arrest
Heart Arrest, Out-Of-Hospital
Bottom Line
View on ClinicalTrials.gov: NCT04153435 ↗Enrolled (actual)
397
Serious AEs
—
Results posted
Feb 2022
Primary outcome: Primary: Number of Participants With Sustained Return of Spontaneous Circulation — 37; 53 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Calcium Chloride (Drug); Sodium chloride 0.9% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lars Wiuff Andersen
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Sustained Return of Spontaneous Circulation |
37; 53 | — |
| SECONDARY Number of Participants With 30-day Survival |
10; 18 | — |
| SECONDARY Number of Participants With 30-day Favorable Neurological Outcome |
7; 15 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04153435). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.