Post-CA Neuroprotection With Magnesium

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Arrest; Return of Spontaneous Circulation
• Intervention / Treatment: Drug: Magnesium Sulfate; Drug: Saline

• Study Type: Interventional
• Enrollment (Estimated): 178
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Anelly Gonzales; Phone Number: 646-501-6923; Email: resuscitationlab@nyulangone.org
• Study Contact Backup: Name: Natalia Leontovich; Phone Number: 646-501-6923; Email: resuscitationlab@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Magnesium Sulfate; Treatment of initial magnesium sulfate bolus followed by a continuous drip.	Drug: Magnesium 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
Placebo Comparator: Saline solution; Treatment of equivalent volume of normal saline.	Drug: Saline; Control subjects will receive an equivalent volume of normal saline intravenously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Sam Parnia, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2025
• Primary Completion (Estimated): March 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: June 7, 2024
• First Submitted That Met QC Criteria: June 7, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Arrest; Sulfur Compounds; Inorganic Chemicals; Chlorine Compounds; Sulfur Acids; Sodium Compounds; Sulfates; Sulfuric Acids; Chlorides; Hydrochloric Acid; Magnesium Compounds; Magnesium Sulfate; Sodium Chloride
• Other Study ID Numbers: 20-00262; 1R34HL166859-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No