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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
178
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
Control subjects will receive an equivalent volume of normal saline intravenously.
NYU Langone Health
New York, New York, United States
RECRUITINGProportion of cases where successful randomization occurred
Time frame: 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)
Time frame: 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.
Time frame: Through study completion, an average of 90 days
Proportion of cases for which serum is successfully drawn and analyzed
Time frame: 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).
Time frame: 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.
Time frame: Day 30
Proportion of cases where patient's CPC status is assessed
The CPC assessment score will be derived from the patient's EMR.
Time frame: Day 90
Number of participants with adverse reactions related to magnesium therapy
Time frame: Through study completion, an average of 90 days
Proportion of cases for which magnesium levels are found to be >6 mg/dl
Time frame: Through study completion, an average of 90 days
Proportion of cases for which magnesium levels are found to be 8.1-10 mg/dl
Time frame: Through study completion, an average of 90 days
Proportion of cases for which magnesium levels are found to be >10 mg/dl
Time frame: Through study completion, an average of 90 days
All-cause mortality
Mortality due to all causes
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Day 90
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