Cardiac Arrest, Return of Spontaneous Circulation
Conditions
Brief summary
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.
Interventions
DRUGMagnesium Sulfate
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
DRUGSaline
Control subjects will receive an equivalent volume of normal saline intravenously.
Sponsors
NYU Langone Health
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Through study completion, an average of 90 days | Assessment of adherence will involve reviewing chart data to evaluate the timing of medication order placement and timing of administration by the nurse. |
| 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 | At hospital discharge, on average 3 weeks | The CPC assessment score will be derived from the patient's electronic medical record (EMR). |
| Proportion of cases where patient's CPC status is assessed | Day 30 | The CPC assessment score will be derived from the patient's EMR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | Day 90 | Mortality due to all causes |
| Proportion of patients with unfavorable neurological outcomes | At hospital discharge, on average 3 weeks | 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). |
Countries
United States
Contacts
CONTACTAnelly Gonzales
CONTACTNatalia Leontovich
PRINCIPAL_INVESTIGATORSam Parnia
NYU Langone Health
Outcome results
None listed