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Recruiting NCT06455514

Post-CA Neuroprotection With Magnesium

Phase I Interventional Cardiac Arrest Return of Spontaneous Circulation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Magnesium Sulfate, Saline.
Who it may be relevant to
Registry conditions: Cardiac Arrest, Return of Spontaneous Circulation. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Neuroprotection Following Cardiac Arrest: A Randomized Control Trial of Magnesium

Overview

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.

Interventions

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

Primary outcome measures

  • Proportion of cases where successful randomization occurred [Time frame: 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) [Time frame: Through study completion, an average of 90 days]
  • Proportion of cases with adherence to treatment protocol [Time frame: Through study completion, an average of 90 days]
  • Proportion of cases for which serum is successfully drawn and analyzed [Time frame: Through study completion, an average of 90 days]
  • Proportion of cases where patient's Cerebral Performance Category Score (CPC) status is assessed [Time frame: At hospital discharge, on average 3 weeks]
  • Proportion of cases where patient's CPC status is assessed [Time frame: Day 30]
  • Proportion of cases where patient's CPC status is assessed [Time frame: Day 90]
Secondary outcome measures (8)
  • Number of participants with adverse reactions related to magnesium therapy [Time frame: Through study completion, an average of 90 days]
  • Proportion of cases for which magnesium levels are found to be >6 mg/dl [Time frame: Through study completion, an average of 90 days]
  • Proportion of cases for which magnesium levels are found to be 8.1-10 mg/dl [Time frame: Through study completion, an average of 90 days]
  • Proportion of cases for which magnesium levels are found to be >10 mg/dl [Time frame: Through study completion, an average of 90 days]
  • All-cause mortality [Time frame: Day 90]
  • Proportion of patients with unfavorable neurological outcomes [Time frame: At hospital discharge, on average 3 weeks]
  • Proportion of patients with unfavorable neurological outcomes [Time frame: Day 30]
  • Proportion of patients with unfavorable neurological outcomes [Time frame: Day 90]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT06455514 · 20-00262 · 1R34HL166859-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗