Administration of calcium during cardiac arrest outside the hospital
Phase 1
- Conditions
- The study will include patients with out-of-hospital cardiac arrest (OHCA). The study will test whether treatment with Calcium Chloride added to standard care will improve survival following OHCA. The study is a double blind placebo controlled trial.MedDRA version: 20.0Level: LLTClassification code 10007517Term: Cardiac arrest transientSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2019-003387-46-DK
- Lead Sponsor
- Research Center for Emergency Medicine Department of Clinical Medicine Aarhus University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 674
Inclusion Criteria
1) OHCA
2) Age = 18 years
3) Received at least one dose of adrenaline during CPR
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 204
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 470
Exclusion Criteria
1) Traumatic OHCA
2) Known or strongly suspected pregnancy
3) Prior enrollment in the trial
4) Already received one dose of adrenaline by a non-participating unit
5) Clinical indication for calcium administration during the cardiac arrest
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine whether calcium administration during adult OHCA will improve return of spontaneous circulation.;Secondary Objective: To determine whether calcium administration during adult OHCA will increase survival at 30 days and survival at 30 days with a favorable neurological outcome (modified Rankin Scale, mRS) ;Primary end point(s): The primary outcome, return of spontaneous circulation (ROSC), has been updated to sustained ROSC. ROSC is defined as palpable pulses or other signs of circulation without a need for chest compressions. Sustained ROSC means that the patient withholds ROSC >20 min. These definitions were made before the initiation of the trial and were included in the first version of the data dictionary (time stamp: January 21st 2020).;Timepoint(s) of evaluation of this end point: The endpoint is evaluated during ongoing cardiopulmonary resuscitation
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Key secondary outcomes will include survival as well as neurological outcome at 30 days. Neurological outcome will be assessed with the modified Rankin Scale (mRS); scores 0-6 will be presented as counts and percentages, while the outcome will be dichotomized as favorable (mRS 0-3) vs. unfavorable (mRS 4-6).;Timepoint(s) of evaluation of this end point: 30 days after the cardiac arrest