Cardiac Arrest Clinical Trial
Official title:
Neuroprotection Following Cardiac Arrest: A Randomized Control Trial of Magnesium
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.
Status | Not yet recruiting |
Enrollment | 178 |
Est. completion date | April 1, 2026 |
Est. primary completion date | April 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: - Documented post-cardiac arrest patient with Return of Spontaneous Circulation (ROSC) achieved <2 hours prior to recruitment Exclusion Criteria: - Age < 18 years or > 85 years - Traumatic cardiac arrests - Unsustained ROSC (<20 minutes) - Patient who is responsive/able to follow motor commands within 1 hour of achieving ROSC - Plan for withdrawal of life support within 72 hours of ROSC - Known pregnant women at the time of the cardiac arrest - Known prisoners at the time of the cardiac arrest - Subjects who have a medical o social condition that would make them inappropriate for the study based on the PI's or clinical team judgement. |
Country | Name | City | State |
---|---|---|---|
United States | NYU Langone Health | New York | New York |
Lead Sponsor | Collaborator |
---|---|
NYU Langone Health | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of cases where successful randomization occurred | Through study completion, an average of 90 days | ||
Primary | 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 | ||
Primary | 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 | |
Primary | Proportion of cases for which serum is successfully drawn and analyzed | Through study completion, an average of 90 days | ||
Primary | 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 | |
Primary | Proportion of cases where patient's CPC status is assessed | The CPC assessment score will be derived from the patient's EMR. | Day 30 | |
Primary | Proportion of cases where patient's CPC status is assessed | The CPC assessment score will be derived from the patient's EMR. | Day 90 | |
Secondary | Number of participants with adverse reactions related to magnesium therapy | Through study completion, an average of 90 days | ||
Secondary | Proportion of cases for which magnesium levels are found to be >6 mg/dl | Through study completion, an average of 90 days | ||
Secondary | Proportion of cases for which magnesium levels are found to be 8.1-10 mg/dl | Through study completion, an average of 90 days | ||
Secondary | Proportion of cases for which magnesium levels are found to be >10 mg/dl | Through study completion, an average of 90 days | ||
Secondary | All-cause mortality | Mortality due to all causes | Day 90 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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