Improving Outcomes in Cardiac Arrest With Inhaled Nitric Oxide

Early Phase 1

• Conditions: Cardiac Arrest
• Interventions: Drug: inhaled nitric oxide

• Registration Number: NCT04134078
• Lead Sponsor: Stony Brook University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Status Verified: 2019-10
• Study First Submitted: 2019-10-17
• Study First Submitted QC: 2019-10-18
• Last Update Submitted: 2019-10-18
• Study First Posted: 2019-10-21
• Last Update Posted: 2019-10-21
• Primary Completion: 2020-07
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
inhaled nitric oxide	inhaled nitric oxide	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.

Primary Outcome Measures

Name	Time	Method
Rate of return of spontanueous circulation (ROSC)	1 day	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
Change in cerebral oxygenation (rSO2)	1 day	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

Secondary Outcome Measures

Name	Time	Method
Neurologic outcomes at hospital discharge	upto 24 weeks	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.
short term survival	upto 24 weeks	Short term survival will include survival from hospital to discharge

Trial Locations

Locations (1)

Stony Brook University; 🇺🇸 S. Setauket, New York, United States