Recruiting
Phase 1

Magnesium Sulfate

Sponsor:

NYU Langone Health

Code:

NCT06455514

Conditions

Cardiac Arrest

Return of Spontaneous Circulation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Magnesium Sulfate

Saline

Study Details

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.

Conditions

Cardiac Arrest

Return of Spontaneous Circulation

Study ID

NCT06455514

Start date

Mar 25, 2025

Status verified date

Apr, 2026

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Mar 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

178 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Magnesium Sulfate

Treatment of initial magnesium sulfate bolus followed by a continuous drip.

placebo comparator: Saline solution

Treatment of equivalent volume of normal saline.

Interventions

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

Saline

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

Primary outcome measure

  • Proportion 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 [ 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 [ Time Frame: At hospital discharge, on average 3 weeks ]
  • Proportion of cases where patient's CPC status is assessed [ Time Frame: Day 30 ]
  • Proportion of cases where patient's CPC status is assessed [ Time Frame: Day 90 ]

Central Contacts and Locations

Central contacts

Anelly Gonzales

646-501-6923resuscitationlab@nyulangone.org

Natalia Leontovich

646-501-6923resuscitationlab@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Apr 7, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-04-07.