Heart Arrest, Out-Of-Hospital
Conditions
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.
Interventions
DRUGCalcium Chloride
Calcium chloride 5 mmol
DRUGSodium chloride 0.9%
Placebo
Sponsors
Central Denmark Region
University of Aarhus
Lars Wiuff Andersen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Calcium 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.
Calcium Chloride: Calcium chloride 5 mmol | 193 |
| Placebo 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.
Sodium chloride 0.9%: Placebo | 198 |
| Total | 391 |
Baseline characteristics
| Characteristic | Calcium | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 67 years STANDARD_DEVIATION 14 | 69 years STANDARD_DEVIATION 14 | 68 years STANDARD_DEVIATION 14 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 62 Participants | 52 Participants | 114 Participants |
| Sex: Female, Male Male | 131 Participants | 146 Participants | 277 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 183 / 193 | 180 / 198 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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.
Time frame: Before or after hospital arrival (up to 2 hours after the cardiac arrest)
Population: Patients were analyzed according to their randomized assignment. The analyses only included patients receiving the first dose of the trial drug and meeting all inclusion criteria and no exclusion criteria.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Calcium | Number of Participants With Sustained Return of Spontaneous Circulation | 37 Participants |
| Placebo | Number of Participants With Sustained Return of Spontaneous Circulation | 53 Participants |
Secondary
Number of Participants With 30-day Favorable Neurological Outcome
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).
Time frame: 30 days after the cardiac arrest
Population: Patients were analyzed according to their randomized assignment. The analyses only included patients receiving the first dose of the trial drug and meeting all inclusion criteria and no exclusion criteria.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Calcium | Number of Participants With 30-day Favorable Neurological Outcome | 7 Participants |
| Placebo | Number of Participants With 30-day Favorable Neurological Outcome | 15 Participants |
Secondary
Number of Participants With 30-day Survival
Time frame: 30 days after the cardiac arrest
Population: Patients were analyzed according to their randomized assignment. The analyses only included patients receiving the first dose of the trial drug and meeting all inclusion criteria and no exclusion criteria.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Calcium | Number of Participants With 30-day Survival | 10 Participants |
| Placebo | Number of Participants With 30-day Survival | 18 Participants |