Cardiac ArrestPhase 1NCT06455514
Post-CA Neuroprotection With Magnesium
A Phase 1 study testing Magnesium Sulfate and Saline in people with Cardiac Arrest and Return of Spontaneous Circulation, run by NYU Langone Health at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cardiac Arrest, Return of Spontaneous Circulation
- What is being tested?
- Magnesium Sulfate and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 178 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2025to 30 Jun 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented post-cardiac arrest patient with Return of Spontaneous Circulation (ROSC) achieved <2 hours prior to recruitment
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
Official title: Neuroprotection Following Cardiac Arrest: A Randomized Control Trial of Magnesium
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.
- Conditions
- Cardiac Arrest, Return of Spontaneous Circulation
- Being tested
- Magnesium Sulfate, Saline
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium SulfateDrug
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
SalineDrug
Control subjects will receive an equivalent volume of normal saline intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Magnesium Sulfate | Experimental | Treatment of initial magnesium sulfate bolus followed by a continuous drip. Receives: Drug: Magnesium Sulfate |
| Saline solution | Placebo comparator | Treatment of equivalent volume of normal saline. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of cases where successful randomization occurred
Measured: 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)
Measured: Through study completion, an average of 90 days
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.
Measured: Through study completion, an average of 90 days
Proportion of cases for which serum is successfully drawn and analyzed
Measured: Through study completion, an average of 90 days
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).
Measured: At hospital discharge, on average 3 weeks
Proportion of cases where patient's CPC status is assessed
The CPC assessment score will be derived from the patient's EMR.
Measured: Day 30
Proportion of cases where patient's CPC status is assessed
The CPC assessment score will be derived from the patient's EMR.
Measured: Day 90
Secondary outcomes (8)
Number of participants with adverse reactions related to magnesium therapy
Measured: Through study completion, an average of 90 days
Proportion of cases for which magnesium levels are found to be >6 mg/dl
Measured: Through study completion, an average of 90 days
Proportion of cases for which magnesium levels are found to be 8.1-10 mg/dl
Measured: Through study completion, an average of 90 days
Proportion of cases for which magnesium levels are found to be >10 mg/dl
Measured: Through study completion, an average of 90 days
All-cause mortality
Mortality due to all causes
Measured: Day 90
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).
Measured: At hospital discharge, on average 3 weeks
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).
Measured: Day 30
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).
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start25 Mar 2025
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Sam Parnia, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06455514
- Sponsor's protocol ID
- 20-00262
- Other IDs
- 1R34HL166859-01A1
- Status last verified
- Apr 2026
- First submitted
- 7 Jun 2024
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Sam.Parnia@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroprotection Following Cardiac Arrest: A Randomized Control Trial of Magnesium
- ClinicalTrials.gov ID
- NCT06455514
- Acronym / sponsor ID
- 20-00262
- Conditions
- Cardiac Arrest, Return of Spontaneous Circulation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium Sulfate | Experimental | Drug: Magnesium SulfateTreatment of initial magnesium sulfate bolus followed by a continuous drip. |
| Saline solution | Placebo comparator | Drug: SalineTreatment of equivalent volume of normal saline. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Documented post-cardiac arrest patient with Return of Spontaneous Circulation (ROSC) achieved <2 hours prior to recruitment
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium Sulfate4 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 | Magnesium Sulfate |
| SalineControl subjects will receive an equivalent volume of normal saline intravenously. | Drug | Saline solution |
Primary outcome
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
Assessment of adherence will involve reviewing chart data to evaluate the timing of medication order placement and timing of administration by the nurse.
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
The CPC assessment score will be derived from the patient's electronic medical record (EMR).
Proportion of cases where patient's CPC status is assessed
Time frame: Day 30
The CPC assessment score will be derived from the patient's EMR.
Proportion of cases where patient's CPC status is assessed
Time frame: Day 90
The CPC assessment score will be derived from the patient's EMR.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Sam.Parnia@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sam Parnia principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Magnesium Sulfate and Saline in people with Cardiac Arrest and Return of Spontaneous Circulation, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anelly Gonzales (646-501-6923, resuscitationlab@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of cases where successful randomization occurred (time frame: Through study completion, an average of 90 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.