Post-CA Neuroprotection With Magnesium

NCT06455514 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 20-002621R34HL166859-01A1
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (7)

• 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

  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

• 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

  The CPC assessment score will be derived from the patient's electronic medical record (EMR).

  At hospital discharge, on average 3 weeks

• Proportion of cases where patient's CPC status is assessed

  The CPC assessment score will be derived from the patient's EMR.

  Day 30

• 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 Outcomes (8)

• 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 >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

• Proportion of cases for which magnesium levels are found to be >10 mg/dl

  Through study completion, an average of 90 days

• All-cause mortality

  Day 90

Study Arms (2)

Magnesium Sulfate

EXPERIMENTAL

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

Drug: Magnesium Sulfate

Saline solution

PLACEBO COMPARATOR

Treatment of equivalent volume of normal saline.

Drug: Saline

Interventions

Magnesium Sulfate 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

Magnesium Sulfate

Saline DRUG

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

Saline solution

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented post-cardiac arrest patient with Return of Spontaneous Circulation (ROSC) achieved \<2 hours prior to recruitment

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Heart Arrest

Interventions

Magnesium Sulfate; Sodium Chloride

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds

Study Officials

• Sam Parnia

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anelly Gonzales

CONTACT

646-501-6923; resuscitationlab@nyulangone.org

Natalia Leontovich

CONTACT

646-501-6923; resuscitationlab@nyulangone.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 12, 2024
• Study Start: March 25, 2025
• Primary Completion: March 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data upon reasonable request. Requests should be directed to Sam.Parnia@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)