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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34HL166859-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The purpose of this pilot interventional study is to collect preliminary data on administering magnesium sulfate as a neuroprotective medication in patients who achieved Return of Spontaneous Circulation (ROSC) following Cardiac Arrest (CA). The primary aims are to assess the feasibility and safety of administering magnesium and measure serum markers of neuronal injury at prespecified time points in the post-cardiac arrest period. Because this is a pilot study with a limited sample size, the primary objective is to evaluate the precision and stability of the collected measures to inform the design and formal analysis in a larger trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnesium Sulfate | Experimental | Treatment of initial magnesium sulfate bolus followed by a continuous drip. |
|
| Saline solution | Placebo Comparator | Treatment of equivalent volume of normal saline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium Sulfate | Drug | 4 g of magnesium sulfate intravenously within 2 hours of Return of Spontaneous Circulation (ROSC), followed by a continuous drip (16 g) over 24 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of cases where successful randomization occurred | Through study completion, an average of 90 days | |
| Proportion of cases where Magnesium (Mg) or saline bolus was delivered with a goal of <2 h after return of spontaneous circulation (ROSC) | Through study completion, an average of 90 days | |
| Proportion of cases with adherence to treatment protocol | Assessment of adherence will involve reviewing chart data to evaluate the timing of medication order placement and timing of administration by the nurse. | Through study completion, an average of 90 days |
| Proportion of cases for which serum is successfully drawn and analyzed | Through study completion, an average of 90 days | |
| Proportion of cases where patient's Cerebral Performance Category Score (CPC) status is assessed | The CPC assessment score will be derived from the patient's electronic medical record (EMR). | At hospital discharge, on average 3 weeks |
| Proportion of cases where patient's CPC status is assessed | The CPC assessment score will be derived from the patient's EMR. | Day 30 |
| Proportion of cases where patient's CPC status is assessed | The CPC assessment score will be derived from the patient's EMR. | Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse reactions related to magnesium therapy | Through study completion, an average of 90 days | |
| Proportion of cases for which magnesium levels are found to be >6 mg/dl | Through study completion, an average of 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anelly Gonzales | Contact | 646-501-6923 | resuscitationlab@nyulangone.org | |
| Natalia Leontovich | Contact | 646-501-6923 | resuscitationlab@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Sam Parnia | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Sam.Parnia@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data upon reasonable request. Requests should be directed to Sam.Parnia@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D008278 | Magnesium Sulfate |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
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| Saline | Drug | Control subjects will receive an equivalent volume of normal saline intravenously. |
|
| Proportion of cases for which magnesium levels are found to be 8.1-10 mg/dl | Through study completion, an average of 90 days |
| Proportion of cases for which magnesium levels are found to be >10 mg/dl | Through study completion, an average of 90 days |
| All-cause mortality | Mortality due to all causes | Day 90 |
| Proportion of patients with unfavorable neurological outcomes | The Cerebral Performance Category (CPC) score is a five-point scale used to assess neurological outcome after cardiac arrest and other events. Scores range from 1 to 5, a score of 1 or 2 is considered a favorable outcome, and scores of 3, 4, or 5 are considered an unfavorable outcome (severe neurological disability, persistent vegetative state or death). | At hospital discharge, on average 3 weeks |
| Proportion of patients with unfavorable neurological outcomes | The Cerebral Performance Category (CPC) score is a five-point scale used to assess neurological outcome after cardiac arrest and other events. Scores range from 1 to 5, a score of 1 or 2 is considered a favorable outcome, and scores of 3, 4, or 5 are considered an unfavorable outcome (severe neurological disability, persistent vegetative state or death). | Day 30 |
| Proportion of patients with unfavorable neurological outcomes | The Cerebral Performance Category (CPC) score is a five-point scale used to assess neurological outcome after cardiac arrest and other events. Scores range from 1 to 5, a score of 1 or 2 is considered a favorable outcome, and scores of 3, 4, or 5 are considered an unfavorable outcome (severe neurological disability, persistent vegetative state or death). | Day 90 |
| D013456 |
| Sulfur Acids |
| D013457 | Sulfur Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D017670 | Sodium Compounds |