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NCT Number: NCT06455514

Post-CA Neuroprotection With 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.

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Key information

Conditions

Cardiac Arrest Cardiovascular Diseases Heart Arrest Heart Diseases Return of Spontaneous Circulation

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Saline

Drug

Control subjects will receive an equivalent volume of normal saline intravenously.

Primary outcomes

  1. Proportion of cases where successful randomization occurred

    Time frame: Through study completion, an average of 90 days

  2. 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

  3. Proportion of cases with adherence to treatment protocol

    Time frame: 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.

  4. Proportion of cases for which serum is successfully drawn and analyzed

    Time frame: Through study completion, an average of 90 days

  5. Proportion of cases where patient's Cerebral Performance Category Score (CPC) status is assessed

    Time frame: At hospital discharge, on average 3 weeks

    The CPC assessment score will be derived from the patient's electronic medical record (EMR).

  6. Proportion of cases where patient's CPC status is assessed

    Time frame: Day 30

    The CPC assessment score will be derived from the patient's EMR.

  7. Proportion of cases where patient's CPC status is assessed

    Time frame: Day 90

    The CPC assessment score will be derived from the patient's EMR.

Secondary outcomes

  1. Number of participants with adverse reactions related to magnesium therapy

    Time frame: Through study completion, an average of 90 days

  2. Proportion of cases for which magnesium levels are found to be >6 mg/dl

    Time frame: Through study completion, an average of 90 days

  3. 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

  4. Proportion of cases for which magnesium levels are found to be >10 mg/dl

    Time frame: Through study completion, an average of 90 days

  5. All-cause mortality

    Time frame: Day 90

    Mortality due to all causes

  6. Proportion of patients with unfavorable neurological outcomes

    Time frame: 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).

  7. Proportion of patients with unfavorable neurological outcomes

    Time frame: Day 30

    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).

  8. Proportion of patients with unfavorable neurological outcomes

    Time frame: Day 90

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Anelly Gonzales

CONTACT

[email protected]

646-501-6923

Natalia Leontovich

CONTACT

[email protected]

646-501-6923

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Neuroprotection Following Cardiac Arrest: A Randomized Control Trial of Magnesium

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 12, 2024
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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