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Trial Outcomes & Findings for Calcium for Out-of-Hospital Cardiac Arrest (NCT NCT04153435)

NCT ID: NCT04153435

Last Updated: 2022-07-25

Results Overview

Palpable pulses or other signs of circulation without a need for chest compressions lasting at least 20 minutes.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

397 participants

Primary outcome timeframe

Before or after hospital arrival (up to 2 hours after the cardiac arrest)

Results posted on

2022-07-25

Participant Flow

Participant milestones

Participant milestones
Measure
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
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
Overall Study
STARTED
197
200
Overall Study
COMPLETED
197
200
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Calcium
n=193 Participants
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
Placebo
n=198 Participants
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
Total
n=391 Participants
Total of all reporting groups
Age, Continuous
67 years
STANDARD_DEVIATION 14 • n=193 Participants
69 years
STANDARD_DEVIATION 14 • n=198 Participants
68 years
STANDARD_DEVIATION 14 • n=391 Participants
Sex: Female, Male
Female
62 Participants
n=193 Participants
52 Participants
n=198 Participants
114 Participants
n=391 Participants
Sex: Female, Male
Male
131 Participants
n=193 Participants
146 Participants
n=198 Participants
277 Participants
n=391 Participants
Race and Ethnicity Not Collected
—
—
0 Participants
Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 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.

Palpable pulses or other signs of circulation without a need for chest compressions lasting at least 20 minutes.

Outcome measures

Outcome measures
Measure
Calcium
n=193 Participants
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
Placebo
n=198 Participants
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
Number of Participants With Sustained Return of Spontaneous Circulation
37 Participants
53 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Calcium
n=193 Participants
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
Placebo
n=198 Participants
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
Number of Participants With 30-day Survival
10 Participants
18 Participants

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure
Calcium
n=193 Participants
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
Placebo
n=198 Participants
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
Number of Participants With 30-day Favorable Neurological Outcome
7 Participants
15 Participants

Adverse Events

Calcium

Serious events: 0 serious events
Other events: 0 other events
Deaths: 183 deaths

Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 180 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lars W. Andersen

Aarhus University

Phone: +4551781511

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place