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Improving Outcomes in Cardiac Arrest With Inhaled Nitric Oxide

Improving Outcomes in Cardiac Arrest With Inhaled Nitric Oxide

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04134078
Enrollment
100
Registered
2019-10-21
Start date
2016-08-31
Completion date
2022-07-31
Last updated
2019-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest

Brief summary

Sudden cardiac arrest (CA) is a leading cause of death worldwide. CA claims the lives of an estimated 300,000 Americans each year. Despite advances in cardiopulmonary resuscitation (CPR) methods, only approximately 10% of adults with CA survive to hospital discharge, and up to 60% of survivors have moderate to severe cognitive deficits 3 months after resuscitation. Most of the immediate and post-CA mortality and morbidity are caused by global ischemic brain injury. The goal of this grant application is to test the hypothesis that resuscitation from cardiac arrest can be improved by improving cerebral oxygenation through inhalation of nitric oxide. This strategy will also improve the chances of return of spontaneous circulation (ROSC), improve short-term survival and neurologic outcome.

Interventions

DRUGinhaled nitric oxide

Inhaled nitric oxide at 40 ppm will be administered upto 24 hours post ROSC in patient who developed in hospital cardiac arrest

Sponsors

Stony Brook University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Age 18 years and above 2. In-hospital cardiac arrest as defined by cessation of heartbeat 3. Presence of Endotracheal Tube

Exclusion criteria

1. Age below 18 years 2. Absence of Endotracheal Tube 3. Patients with out-of-hospital cardiac arrest 4. Patients involved in trauma and/or patients in the SICU or CTICU 5. Preexisting intra-cerebral lesions such as any head injury (old or new), brain hematoma, cerebral hemorrhage or known frontal lobe disorders such as tumors 6. Any patient with a terminal condition that cannot be treated (specifically any terminal malignancy, end stage lung fibrosis, chronic heart failure with an ejection fraction \<20%) 7. Patients with do not resuscitate and/or do not intubate (DNR/DNI) status 8. Therapeutic window has passed

Design outcomes

Primary

MeasureTime frameDescription
Rate of return of spontanueous circulation (ROSC)1 dayThe primary outcome measure is to evaluate rates of return of spontaneous circulation (ROSC) from in hospital cardiac arrest patient who receive inhaled nitric oxide
Change in cerebral oxygenation (rSO2)1 dayThe outcomes measure is to evaluate change in the concentration of cerebral oxygenation measured by Near-infrared spectroscopy before and after the administration of inhaled nitric oxide

Secondary

MeasureTime frameDescription
Neurologic outcomes at hospital dischargeupto 24 weeksPatient who suffered in hospital cardiac arrest has variable neurologic outcomes. This will be evaluated with Glasgow outcome scale (GOS). This score ranges from 1 to 5 where GOS 1-3 is considered unfavourable neurologic outcomes and GOS 4-5 are considered favourable neurologic outcomes.
short term survivalupto 24 weeksShort term survival will include survival from hospital to discharge

Countries

United States

Contacts

Primary ContactJignesh Patel, MD
jignesh.patel@stonybrookmedicine.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026