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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-003387-46 | EudraCT Number |
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| Name | Class |
|---|---|
| Central Denmark Region | OTHER |
| University of Aarhus | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium Chloride | Drug | Calcium chloride 5 mmol |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With 30-day Survival | 30 days after the cardiac arrest | |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars W Andersen | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prehospital Emergency Medical Services | Aarhus N | Central Jutland | 8200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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 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. | |
| 34847226 |
| Label | URL |
|---|---|
| Trial website | View source |
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Six months after the publication of the last results, all deidentified individual patient data will be made available for data sharing. Procedures, including re-coding of key variables, will be put in place to allow for complete deidentification of the data. Data will be completely anonymized according to Danish law.
Six months after the publication of the last results
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All patients received the trial drug and meeting all inclusion criteria and none of the exclusion criteria.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | Before or after hospital arrival (up to 2 hours after the cardiac arrest) |
|
30 days
Adverse events were not collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lars W. Andersen | Aarhus University | +4551781511 | lwandersen@clin.au.dk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 21, 2020 | Jan 11, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D058687 | Out-of-Hospital Cardiac Arrest |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D002122 | Calcium Chloride |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
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| Sodium chloride 0.9% | Drug | Placebo |
|
| 30 days after the cardiac arrest |
| 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. |
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 |
| 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 |
|
|
| Secondary | Number of Participants With 30-day Survival | 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. | Posted | Count of Participants | Participants | 30 days after the cardiac arrest |
|
|
|
| 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). | 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. | Posted | Count of Participants | Participants | 30 days after the cardiac arrest |
|
|
|
| 183 |
| 193 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 | 180 | 198 | 0 | 0 | 0 | 0 |
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| D017606 |
| Chlorine Compounds |
| D017670 | Sodium Compounds |