Post-CA Neuroprotection With Magnesium
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-85
SponsorNYU Langone Health
About this trial
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
This trial does not accept healthy volunteersQualifiers
Documented post-cardiac arrest patient with Return of Spontaneous Circulation (ROSC) achieved <2 hours prior to recruitment
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Magnesium Sulfate
Drug4 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
DrugControl subjects will receive an equivalent volume of normal saline intravenously.
Treatment groups
178 Participants
are divided into 2 treatment groupsGroup A: Magnesium SulfateExperimental treatment 1 intervention
Group B: Saline solutionPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of cases where successful randomization occurred
Time frame
Through study completion, an average of 90 days2
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 days3
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.
Time frame
Through study completion, an average of 90 days4
Proportion of cases for which serum is successfully drawn and analyzed
Time frame
Through study completion, an average of 90 daysSecondary outcomes
1
Number of participants with adverse reactions related to magnesium therapy
Time frame
Through study completion, an average of 90 days2
Proportion of cases for which magnesium levels are found to be >6 mg/dl
Time frame
Through study completion, an average of 90 days3
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 days4
Proportion of cases for which magnesium levels are found to be >10 mg/dl
Time frame
Through study completion, an average of 90 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
NYU Langone Health
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov