Clinical trial NCT04153435: Calcium for Out-of-Hospital Cardiac Arrest
Official title: Calcium for Out-of-Hospital Cardiac Arrest - A Randomized, Double-Blind, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Arrest, Out-Of-Hospital
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: Central Denmark Region
name: University of Aarhus
First posted: 2019-11-06
Enrollment: 397
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants With Sustained Return of Spontaneous Circulation
timeFrame: Before or after hospital arrival (up to 2 hours after the cardiac arrest)
Secondary outcomes:
measure: Number of Participants With 30-day Survival
timeFrame: 30 days after the cardiac arrest
measure: Number of Participants With 30-day Favorable Neurological Outcome
timeFrame: 30 days after the cardiac arrest
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Prehospital Emergency Medical Services
state: Central Denmark Region
Study officials:
affiliation: Aarhus University Hospital
name: Lars W Andersen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vallentin MF, Granfeldt A, Meilandt C, Povlsen AL, Sindberg B, Holmberg MJ, Iversen BN, Maerkedahl R, Mortensen LR, Nyboe R, Vandborg MP, Tarpgaard M, Runge C, Christiansen CF, Dissing TH, Terkelsen CJ, Christensen S, Kirkegaard H, Andersen LW. Effect of calcium vs. placebo on long-term outcomes in patients with out-of-hospital cardiac arrest. Resuscitation. 2022 Oct;179:21-24. doi: 10.1016/j.resuscitation.2022.07.034. Epub 2022 Jul 30.
citation: Vallentin MF, Granfeldt A, Meilandt C, Povlsen AL, Sindberg B, Holmberg MJ, Iversen BN, Maerkedahl R, Mortensen LR, Nyboe R, Vandborg MP, Tarpgaard M, Runge C, Christiansen CF, Dissing TH, Terkelsen CJ, Christensen S, Kirkegaard H, Andersen LW. Effect of Intravenous or Intraosseous Calcium vs Saline on Return of Spontaneous Circulation in Adults With Out-of-Hospital Cardiac Arrest: A Randomized Clinical Trial. JAMA. 2021 Dec 14;326(22):2268-2276. doi: 10.1001/jama.2021.20929.