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Clinical Trials/NCT04134078
NCT04134078
Unknown
Early Phase 1

Improving Outcomes in Cardiac Arrest With Inhaled Nitric Oxide

Stony Brook University1 site in 1 country100 target enrollmentAugust 2016

Overview

Phase
Early Phase 1
Intervention
inhaled nitric oxide
Conditions
Cardiac Arrest
Sponsor
Stony Brook University
Enrollment
100
Locations
1
Primary Endpoint
Rate of return of spontanueous circulation (ROSC)
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2016
End Date
July 2022
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jignesh Patel

Associate Professor of Medicine

Stony Brook University

Eligibility Criteria

Inclusion Criteria

  • Age 18 years and above
  • In-hospital cardiac arrest as defined by cessation of heartbeat
  • Presence of Endotracheal Tube

Exclusion Criteria

  • Age below 18 years
  • Absence of Endotracheal Tube
  • Patients with out-of-hospital cardiac arrest
  • Patients involved in trauma and/or patients in the SICU or CTICU
  • Preexisting intra-cerebral lesions such as any head injury (old or new), brain hematoma, cerebral hemorrhage or known frontal lobe disorders such as tumors
  • 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%)
  • Patients with do not resuscitate and/or do not intubate (DNR/DNI) status
  • Therapeutic window has passed

Arms & Interventions

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.

Intervention: inhaled nitric oxide

Outcomes

Primary Outcomes

Rate of return of spontanueous circulation (ROSC)

Time Frame: 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)

Time Frame: 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 Outcomes

  • Neurologic outcomes at hospital discharge(upto 24 weeks)
  • short term survival(upto 24 weeks)

Study Sites (1)

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