Improving Outcomes in Cardiac Arrest With Inhaled Nitric Oxide

NCT ID: NCT04134078

Last Updated: 2019-10-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2022-07-31

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

inhaled nitric oxide

Intervention Type: DRUG

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

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stony Brook University

OTHER

Sponsor Role: lead

Responsible Party

Jignesh Patel

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jignesh K Patel, MD

Role: PRINCIPAL_INVESTIGATOR

Stony Brook University

Locations

Stony Brook University

South Setauket, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jignesh Patel, MD

Role: CONTACT

jignesh.patel@stonybrookmedicine.edu

Facility Contacts

Jignesh K Patel, MD

Role: primary

jignesh.patel@stonybrookmedicine.edu

References

Patel JK, Schoenfeld E, Hou W, Singer A, Rakowski E, Ahmad S, Patel R, Parikh PB, Smaldone G. Inhaled nitric oxide in adults with in-hospital cardiac arrest: A feasibility study. Nitric Oxide. 2021 Oct 1;115:30-33. doi: 10.1016/j.niox.2021.07.001. Epub 2021 Jul 3.

Reference Type: DERIVED

PMID: 34229057 (View on PubMed)

Magliocca A, Fries M. Inhaled gases as novel neuroprotective therapies in the postcardiac arrest period. Curr Opin Crit Care. 2021 Jun 1;27(3):255-260. doi: 10.1097/MCC.0000000000000820.

Reference Type: DERIVED

PMID: 33769417 (View on PubMed)

Other Identifiers

648019

Identifier Type: -

Identifier Source: org_study_id