Improving Outcomes in Cardiac Arrest With Inhaled Nitric Oxide

Improving Outcomes in Cardiac Arrest With Inhaled Nitric Oxide

Sponsors

Lead sponsor: Stony Brook University

Source 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.

Overall Status Recruiting
Start Date August 2016
Completion Date July 2022
Primary Completion Date July 2020
Phase Early Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Rate of return of spontanueous circulation (ROSC) 1 day
Change in cerebral oxygenation (rSO2) 1 day
Secondary Outcome
Measure Time Frame
Neurologic outcomes at hospital discharge upto 24 weeks
short term survival upto 24 weeks
Enrollment 100
Condition
Intervention

Intervention type: Drug

Intervention name: inhaled nitric oxide

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

Arm group label: inhaled nitric oxide

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Jignesh K Patel, MD Principal Investigator Stony Brook University
Overall Contact

Last name: Jignesh Patel, MD

Email: [email protected]

Location
facility status contact Stony Brook University Jignesh K Patel, MD [email protected]
Location Countries

United States

Verification Date

October 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Stony Brook University

Investigator full name: Jignesh Patel

Investigator title: Associate Professor of Medicine

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: inhaled nitric oxide

Arm group type: Experimental

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.

Patient Data No
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov