Post-CA Neuroprotection With Magnesium

NYU Langone Health

Status and phase: Enrolling; Phase 1

Conditions: Return of Spontaneous Circulation; Cardiac Arrest

Treatments: Drug: Saline; Drug: Magnesium Sulfate

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06455514

1R34HL166859-01A1 (U.S. NIH Grant/Contract)

20-00262

Details and patient eligibility

About

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.

Enrollment: 178 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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178 participants in 2 patient groups, including a placebo group

Magnesium Sulfate

Experimental group

Description:

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

Treatment:

Drug: Magnesium Sulfate

Saline solution

Placebo Comparator group

Description:

Treatment of equivalent volume of normal saline.

Treatment:

Drug: Saline