Recruiting
Early Phase 1

Inhalation of Nitric Oxide

Sponsor:

Stony Brook University

Code:

NCT04134078

Conditions

Cardiac Arrest

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

inhaled nitric oxide

Study Details

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.

Conditions

Cardiac Arrest

Study ID

NCT04134078

Start date

Aug, 2016

Status verified date

Oct, 2019

Completion date

Jul, 2022

Anticipated

Primary completion date

Jul, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

inhaled nitric oxide

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

Primary outcome measure

  • Rate of return of spontanueous circulation (ROSC) [ Time Frame: 1 day ]
  • Change in cerebral oxygenation (rSO2) [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

Jignesh Patel, MD

jignesh.patel@stonybrookmedicine.edu

Locations

Stony Brook University

Recruiting

S. Setauket, New York, United States, 11720

Contacts

Jignesh K Patel, MD

jignesh.patel@stonybrookmedicine.edu

More Information

Sponsor

Stony Brook University

Last update posted

Oct 21, 2019

Last verified

Oct, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stony Brook University on 2019-10-21.