[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06455514":3,"trial-entities:NCT06455514":120,"trial-summary:NCT06455514":123},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":40,"secondary_outcomes":61,"sex":78,"minimum_age":79,"maximum_age":80,"healthy_volunteers":81,"eligibility_criteria":82,"std_ages":95,"locations":98,"central_contacts":106,"overall_officials":114,"references":118,"see_also_links":119},"NCT06455514","20-00262","Post-CA Neuroprotection With Magnesium","Neuroprotection Following Cardiac Arrest: A Randomized Control Trial of Magnesium","RECRUITING","2026-06-30","2026-04","2026-04-07","2025-03-25","NYU Langone Health","OTHER",true,"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.",null,[19,20],"Cardiac Arrest","Return of Spontaneous Circulation",[],"INTERVENTIONAL","PREVENTION",[25],"PHASE1",{"count":27,"type":28},178,"ESTIMATED",[30,35],{"type":31,"name":32,"description":33,"armGroupLabels":34},"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",[32],{"type":31,"name":36,"description":37,"armGroupLabels":38},"Saline","Control subjects will receive an equivalent volume of normal saline intravenously.",[39],"Saline solution",[41,44,46,49,51,55,59],{"measure":42,"timeFrame":43},"Proportion of cases where successful randomization occurred","Through study completion, an average of 90 days",{"measure":45,"timeFrame":43},"Proportion of cases where Magnesium (Mg) or saline bolus was delivered with a goal of \u003C2 h after return of spontaneous circulation (ROSC)",{"measure":47,"description":48,"timeFrame":43},"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.",{"measure":50,"timeFrame":43},"Proportion of cases for which serum is successfully drawn and analyzed",{"measure":52,"description":53,"timeFrame":54},"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",{"measure":56,"description":57,"timeFrame":58},"Proportion of cases where patient's CPC status is assessed","The CPC assessment score will be derived from the patient's EMR.","Day 30",{"measure":56,"description":57,"timeFrame":60},"Day 90",[62,64,66,68,70,73,76,77],{"measure":63,"timeFrame":43},"Number of participants with adverse reactions related to magnesium therapy",{"measure":65,"timeFrame":43},"Proportion of cases for which magnesium levels are found to be >6 mg\u002Fdl",{"measure":67,"timeFrame":43},"Proportion of cases for which magnesium levels are found to be 8.1-10 mg\u002Fdl",{"measure":69,"timeFrame":43},"Proportion of cases for which magnesium levels are found to be >10 mg\u002Fdl",{"measure":71,"description":72,"timeFrame":60},"All-cause mortality","Mortality due to all causes",{"measure":74,"description":75,"timeFrame":54},"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).",{"measure":74,"description":75,"timeFrame":58},{"measure":74,"description":75,"timeFrame":60},"ALL","18 Years","85 Years",false,{"inclusion":83,"exclusion":85,"raw_text":94},[84],"Documented post-cardiac arrest patient with Return of Spontaneous Circulation (ROSC) achieved \\\u003C2 hours prior to recruitment",[86,87,88,89,90,91,92,93],"Age \\\u003C 18 years or \\> 85 years","Traumatic cardiac arrests","Unsustained ROSC (\\\u003C20 minutes)","Patient who is responsive\u002Fable 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.","Inclusion Criteria:\n\n* Documented post-cardiac arrest patient with Return of Spontaneous Circulation (ROSC) achieved \\\u003C2 hours prior to recruitment\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years or \\> 85 years\n* Traumatic cardiac arrests\n* Unsustained ROSC (\\\u003C20 minutes)\n* Patient who is responsive\u002Fable to follow motor commands within 1 hour of achieving ROSC\n* Plan for withdrawal of life support within 72 hours of ROSC\n* Known pregnant women at the time of the cardiac arrest\n* Known prisoners at the time of the cardiac arrest\n* 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.",[96,97],"ADULT","OLDER_ADULT",[99],{"facility":13,"status":8,"city":100,"state":100,"zip":101,"country":102,"geoPoint":103},"New York","10016","United States",{"lat":104,"lon":105},40.71427,-74.00597,[107,112],{"name":108,"role":109,"phone":110,"email":111},"Anelly Gonzales","CONTACT","646-501-6923","resuscitationlab@nyulangone.org",{"name":113,"role":109,"phone":110,"email":111},"Natalia Leontovich",[115],{"name":116,"affiliation":13,"role":117},"Sam Parnia","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":121,"biomarkers":122},[19],[],{"nct_id":4,"found":15,"summary":124,"prompt_version":134},{"design":125,"status":126,"heading":127,"summary":128,"follow_up":129,"word_count":130,"commitments":131,"compensation":132,"drugs_mentioned":133},"This is an interventional study with 178 planned participants. It compares magnesium sulfate to saline.","completed","Magnesium for Neuroprotection After Cardiac Arrest","This study is looking at whether magnesium sulfate can help protect the brain after a cardiac arrest (when the heart stops beating) and return of spontaneous circulation (ROSC, when the heart starts beating again). You might be able to join if you are between 18 and 85 years old and have experienced a cardiac arrest with ROSC within the last two hours. Researchers want to see if it's safe and possible to give magnesium sulfate or a saline (saltwater) placebo within two hours of ROSC. The main goals are to check how well the study can be run and to gather early information for a larger future study. This study is currently unclear on its recruitment status and plans to enroll 178 participants.","Participants will be followed through study completion, which is an average of 90 days.",123,"Not specified in the trial record.","Not stated in the trial record.",[32,36],"v2"]