- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04134078
Improving Outcomes in Cardiac Arrest With Inhaled Nitric Oxide
October 18, 2019 updated by: Jignesh Patel, Stony Brook University
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jignesh Patel, MD
- Email: jignesh.patel@stonybrookmedicine.edu
Study Locations
-
-
New York
-
S. Setauket, New York, United States, 11720
- Recruiting
- Stony Brook University
-
Contact:
- Jignesh K Patel, MD
- Email: jignesh.patel@stonybrookmedicine.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
Inhaled nitric oxide at 40 ppm will be administered upto 24 hours post ROSC in patient who developed in hospital cardiac arrest
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 day
|
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
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
upto 24 weeks
|
short term survival
Time Frame: upto 24 weeks
|
Short term survival will include survival from hospital to discharge
|
upto 24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jignesh K Patel, MD, Stony Brook University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2016
Primary Completion (Anticipated)
July 1, 2020
Study Completion (Anticipated)
July 1, 2022
Study Registration Dates
First Submitted
October 17, 2019
First Submitted That Met QC Criteria
October 18, 2019
First Posted (Actual)
October 21, 2019
Study Record Updates
Last Update Posted (Actual)
October 21, 2019
Last Update Submitted That Met QC Criteria
October 18, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Heart Arrest
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Protective Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Antioxidants
- Free Radical Scavengers
- Endothelium-Dependent Relaxing Factors
- Gasotransmitters
- Nitric Oxide
Other Study ID Numbers
- 648019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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