Improving Outcomes in Cardiac Arrest With Inhaled Nitric Oxide

Stony Brook University

Status and phase: Unknown; Early Phase 1

Conditions: Cardiac Arrest

Treatments: Drug: inhaled nitric oxide

Study type: Interventional

Funder types: Other

Identifiers

NCT04134078

648019

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

inhaled nitric oxide

Experimental group

Description:

Inhaled Nitric Oxide at 40 ppm will be administered in adults who suffer in hospital cardiac arrest. The administration of inhaled nitric oxide at 40 ppm will be provided upto 24 hours once ROSC is achieved.

Treatment:

Drug: inhaled nitric oxide