Calcium for Out-of-Hospital Cardiac Arrest

NCT04153435 | Completed Phase 2 Results DMC

• 2 other identifiers: 000022019-003387-46
• Study Type: interventional
• Target: 397
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Arrest, Out-Of-Hospital

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

Calcium

EXPERIMENTAL

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.

Drug: Calcium Chloride

Placebo

PLACEBO COMPARATOR

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.

Drug: Sodium chloride 0.9%

Interventions

Calcium Chloride DRUG

Calcium chloride 5 mmol

Also known as: CaCl2

Calcium

Sodium chloride 0.9% DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Out-of-hospital cardiac arrest
• Age ≥ 18 years
• Received at least one dose of adrenaline

You may not qualify if:

• 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

Sponsors & Collaborators

• Lars Wiuff Andersen: lead
• Central Denmark Region: collaborator
• University of Aarhus: collaborator

Study Sites (1)

Prehospital Emergency Medical Services

Aarhus N, Central Jutland, 8200, Denmark

Location

Related Publications (2)

• 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.

  PMID: 35917866 DERIVED

• 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.

  PMID: 34847226 DERIVED

Related Links

• Trial website

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Interventions

Calcium Chloride; Sodium Chloride

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds

Results Point of Contact

• Title: Lars W. Andersen
• Organization: Aarhus University

lwandersen@clin.au.dk

+4551781511

Study Officials

• Lars W Andersen

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 3, 2019
• First Posted: November 6, 2019
• Study Start: January 20, 2020
• Primary Completion: April 15, 2021
• Study Completion: April 15, 2022
• Last Updated: July 25, 2022
• Results First Posted: February 25, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Six months after the publication of the last results
• Access Criteria: Data will be available for any research purpose to all interested parties who have approval from an independent review committee and who have a methodological sound proposal as determined by the steering committee of the current trial. Only the methodological qualities and not the purpose or objective of the proposal will be considered.

Locations

DK (1)