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Improving Outcomes in Cardiac Arrest With Inhaled Nitric Oxide

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04134078
Recruitment Status : Recruiting
First Posted : October 21, 2019
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
Jignesh Patel, 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.

Condition or disease Intervention/treatment Phase
Cardiac Arrest Drug: inhaled nitric oxide Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Outcomes in Cardiac Arrest With Inhaled Nitric Oxide
Actual Study Start Date : August 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: 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 Measures :
  1. 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

  2. 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 Outcome Measures :
  1. Neurologic outcomes at hospital discharge [ Time Frame: 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.

  2. short term survival [ Time Frame: upto 24 weeks ]
    Short term survival will include survival from hospital to discharge



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04134078


Contacts
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Contact: Jignesh Patel, MD jignesh.patel@stonybrookmedicine.edu

Locations
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United States, New York
Stony Brook University Recruiting
S. Setauket, New York, United States, 11720
Contact: Jignesh K Patel, MD       jignesh.patel@stonybrookmedicine.edu   
Sponsors and Collaborators
Stony Brook University
Investigators
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Principal Investigator: Jignesh K Patel, MD Stony Brook University
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Responsible Party: Jignesh Patel, Associate Professor of Medicine, Stony Brook University
ClinicalTrials.gov Identifier: NCT04134078    
Other Study ID Numbers: 648019
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Arrest
Heart Diseases
Cardiovascular Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents