Post-CA Neuroprotection With Magnesium

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-25

Study Completion Date

2026-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Cardiac Arrest Return of Spontaneous Circulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Magnesium Sulfate

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

Group Type EXPERIMENTAL

Magnesium Sulfate

Intervention Type 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 solution

Treatment of equivalent volume of normal saline.

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Saline

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No