Post-CA Neuroprotection With Magnesium

Phase 1

Recruiting

• Conditions: Cardiac Arrest; Return of Spontaneous Circulation
• Interventions: Drug: Magnesium Sulfate; Drug: Saline

• Registration Number: NCT06455514
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-07
• Study First Submitted QC: 2024-06-07
• Study First Posted: 2024-06-12
• Study Start: 2025-03-25
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-22
• Primary Completion: 2026-04-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 178

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnesium Sulfate	Magnesium Sulfate	Treatment of initial magnesium sulfate bolus followed by a continuous drip.
Saline solution	Saline	Treatment of equivalent volume of normal saline.

Primary Outcome Measures

Name	Time	Method
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	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.
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	At hospital discharge, on average 3 weeks	The CPC assessment score will be derived from the patient's electronic medical record (EMR).
Proportion of cases where patient's CPC status is assessed	Day 90	The CPC assessment score will be derived from the patient's EMR.

Secondary Outcome Measures

Name	Time	Method
All-cause mortality	Day 90	Mortality due to all causes
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
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 >10 mg/dl	Through study completion, an average of 90 days
Proportion of patients with unfavorable neurological outcomes	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).

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States