Clinical trial NCT06455514: Post-CA Neuroprotection With Magnesium
Official title: Neuroprotection Following Cardiac Arrest: A Randomized Control Trial of Magnesium
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Cardiac Arrest
Return of Spontaneous Circulation
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-06-12
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Proportion of cases where successful randomization occurred
timeFrame: Through study completion, an average of 90 days
measure: Proportion of cases where Magnesium (Mg) or saline bolus was delivered with a goal of <2 h after return of spontaneous circulation (ROSC)
timeFrame: Through study completion, an average of 90 days
measure: Proportion of cases with adherence to treatment protocol
timeFrame: Through study completion, an average of 90 days
measure: Proportion of cases for which serum is successfully drawn and analyzed
timeFrame: Through study completion, an average of 90 days
measure: Proportion of cases where patient's Cerebral Performance Category Score (CPC) status is assessed
timeFrame: At hospital discharge, on average 3 weeks
measure: Proportion of cases where patient's CPC status is assessed
timeFrame: Day 30
measure: Proportion of cases where patient's CPC status is assessed
timeFrame: Day 90
Secondary outcomes:
measure: Number of participants with adverse reactions related to magnesium therapy
timeFrame: Through study completion, an average of 90 days
measure: Proportion of cases for which magnesium levels are found to be >6 mg/dl
timeFrame: Through study completion, an average of 90 days
measure: Proportion of cases for which magnesium levels are found to be 8.1-10 mg/dl
timeFrame: Through study completion, an average of 90 days
measure: Proportion of cases for which magnesium levels are found to be >10 mg/dl
timeFrame: Through study completion, an average of 90 days
measure: All-cause mortality
timeFrame: Day 90
measure: Proportion of patients with unfavorable neurological outcomes
timeFrame: At hospital discharge, on average 3 weeks
measure: Proportion of patients with unfavorable neurological outcomes
timeFrame: Day 30
measure: Proportion of patients with unfavorable neurological outcomes
timeFrame: Day 90
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Sam Parnia
role: PRINCIPAL_INVESTIGATOR
References: