Improving Outcomes in Cardiac Arrest With Inhaled Nitric Oxide

Early Phase 1UnknownNCT04134078

Stony Brook University100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Cardiac Arrest

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Rate of return of spontanueous circulation (ROSC)

The primary outcome measure is to evaluate rates of return of spontaneous circulation (ROSC) from in hospital cardiac arrest patient who receive inhaled nitric oxide

Time frame: 1 day

Change in cerebral oxygenation (rSO2)

The 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

Time frame: 1 day

Secondary Outcomes

Neurologic outcomes at hospital discharge

Patient 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.

Time frame: upto 24 weeks

short term survival

Short term survival will include survival from hospital to discharge