Post-CA Neuroprotection With Magnesium

Cardiac Arrest Clinical Trial

Official title:

Neuroprotection Following Cardiac Arrest: A Randomized Control Trial of Magnesium

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06455514
• Other study ID #: 20-00262
• Secondary ID: 1R34HL166859-01A
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: August 1, 2024
• Est. completion date: April 1, 2026

Study information

• Verified date: June 2024
• Source: NYU Langone Health
• Contact: Anelly Gonzales
• Phone: 646-501-6923
• Email: resuscitationlab[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 178
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Return of Spontaneous Circulation

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of cases where successful randomization occurred		Through study completion, an average of 90 days
Primary	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
Primary	Proportion of cases with adherence to treatment protocol	Assessment of adherence will involve reviewing chart data to evaluate the timing of medication order placement and timing of administration by the nurse.	Through study completion, an average of 90 days
Primary	Proportion of cases for which serum is successfully drawn and analyzed		Through study completion, an average of 90 days
Primary	Proportion of cases where patient's Cerebral Performance Category Score (CPC) status is assessed	The CPC assessment score will be derived from the patient's electronic medical record (EMR).	At hospital discharge, on average 3 weeks
Primary	Proportion of cases where patient's CPC status is assessed	The CPC assessment score will be derived from the patient's EMR.	Day 30
Primary	Proportion of cases where patient's CPC status is assessed	The CPC assessment score will be derived from the patient's EMR.	Day 90
Secondary	Number of participants with adverse reactions related to magnesium therapy		Through study completion, an average of 90 days
Secondary	Proportion of cases for which magnesium levels are found to be >6 mg/dl		Through study completion, an average of 90 days
Secondary	Proportion of cases for which magnesium levels are found to be 8.1-10 mg/dl		Through study completion, an average of 90 days
Secondary	Proportion of cases for which magnesium levels are found to be >10 mg/dl		Through study completion, an average of 90 days
Secondary	All-cause mortality	Mortality due to all causes	Day 90
Secondary	Proportion of patients with unfavorable neurological outcomes	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).	At hospital discharge, on average 3 weeks
Secondary	Proportion of patients with unfavorable neurological outcomes	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).	Day 30
Secondary	Proportion of patients with unfavorable neurological outcomes	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).	Day 90