Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06455514
Other study ID # 20-00262
Secondary ID 1R34HL166859-01A
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date August 1, 2024
Est. completion date April 1, 2026

Study information

Verified date June 2024
Source NYU Langone Health
Contact Anelly Gonzales
Phone 646-501-6923
Email resuscitationlab@nyulangone.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 178
Est. completion date April 1, 2026
Est. primary completion date April 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States NYU Langone Health New York New York

Sponsors (2)

Lead Sponsor Collaborator
NYU Langone Health National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of cases where successful randomization occurred Through study completion, an average of 90 days
Primary 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
Primary 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
Primary Proportion of cases for which serum is successfully drawn and analyzed Through study completion, an average of 90 days
Primary 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
Primary Proportion of cases where patient's CPC status is assessed The CPC assessment score will be derived from the patient's EMR. Day 30
Primary 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 Number of participants with adverse reactions related to magnesium therapy Through study completion, an average of 90 days
Secondary Proportion of cases for which magnesium levels are found to be >6 mg/dl Through study completion, an average of 90 days
Secondary Proportion of cases for which magnesium levels are found to be 8.1-10 mg/dl Through study completion, an average of 90 days
Secondary Proportion of cases for which magnesium levels are found to be >10 mg/dl Through study completion, an average of 90 days
Secondary All-cause mortality Mortality due to all causes Day 90
Secondary 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). At hospital discharge, on average 3 weeks
Secondary 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). Day 30
Secondary 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). Day 90
See also
  Status Clinical Trial Phase
Recruiting NCT06048068 - Removing Surrogates' Uncertainty to Reduce Fear and Anxiety After Cardiac Events N/A
Recruiting NCT05558228 - Accuracy of Doppler Ultrasound Versus Manual Palpation of Pulse in Cardiac Arrest
Completed NCT03685383 - Cytokine Adsorption in Post-cardiac Arrest Syndrome in Patients Requiring Extracorporeal Cardiopulmonary Resuscitation N/A
Completed NCT04584645 - A Digital Flu Intervention for People With Cardiovascular Conditions N/A
Completed NCT04619498 - Effectiveness of an Interactive Cognitive Support Tablet App to Improve the Management of Pediatric Cardiac Arrest N/A
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Withdrawn NCT02352350 - Lactate in Cardiac Arrest N/A
Completed NCT03024021 - Cerebral Oxymetry and Neurological Outcome in Therapeutic Hypothermia
Completed NCT02275234 - Care After Resuscitation
Completed NCT02247947 - Proteomics to Identify Prognostic Markers After CPR and to Estimate Neurological Outcome
Completed NCT01944605 - Intestinal Ischemia as a Stimulus for Systemic Inflammatory Response After Cardiac Arrest N/A
Completed NCT01936597 - Prospective Study of 3 Phone Assistance Strategies to Achieve a Continuous Cardiac Massage N/A
Completed NCT01972087 - Simulation Training to Improve 911 Dispatcher Identification of Cardiac Arrest N/A
Active, not recruiting NCT01239420 - Norwegian Cardio-Respiratory Arrest Study
Completed NCT00880087 - Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-IH [In Hospital] Trial N/A
Completed NCT00878644 - Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-OH [Out of Hospital] Trial Phase 3
Completed NCT01191736 - Ultra-Brief Versus Brief Hands Only CPR Video Training With and Without Psychomotor Skill Practice N/A
Completed NCT00729794 - Vasopressin, Epinephrine, and Steroids for Cardiac Arrest Phase 3
Recruiting NCT00441753 - Cerebral Bloodflow and Carbondioxide Reactivity During Mild Therapeutic Hypothermia in Patients After Cardiac Arrest N/A
Completed NCT00347477 - Fluid Shifts in Patients Treated With Therapeutic Hypothermia After Cardiac Arrest Phase 3