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Improving Outcomes in Cardiac Arrest With Inhaled Nitric Oxide

Primary Purpose

Cardiac Arrest

Status

Unknown status

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

inhaled nitric oxide

About this trial

This is an interventional treatment trial for Cardiac Arrest

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Stony Brook UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

inhaled nitric oxide

Arm Description

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.

Outcomes

Primary Outcome Measures

Rate of return of spontanueous circulation (ROSC)

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)

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

Neurologic outcomes at hospital discharge

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.

short term survival

Short term survival will include survival from hospital to discharge

Full Information

NCT ID

NCT04134078

First Posted

October 17, 2019

Last Updated

October 18, 2019

Sponsor

Stony Brook University

1. Study Identification

Unique Protocol Identification Number

NCT04134078

Brief Title

Improving Outcomes in Cardiac Arrest With Inhaled Nitric Oxide

Official Title

Improving Outcomes in Cardiac Arrest With Inhaled Nitric Oxide

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Unknown status

Study Start Date

August 2016 (Actual)

Primary Completion Date

July 2020 (Anticipated)

Study Completion Date

July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stony Brook University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiac Arrest

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

inhaled nitric oxide

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

inhaled nitric oxide

Intervention Description

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 Information:

Title

Rate of return of spontanueous circulation (ROSC)

Description

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

Time Frame

1 day

Title

Change in cerebral oxygenation (rSO2)

Description

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

Time Frame

1 day

Secondary Outcome Measure Information:

Title

Neurologic outcomes at hospital discharge

Description

Time Frame

upto 24 weeks

Title

short term survival

Description

Short term survival will include survival from hospital to discharge

Time Frame

upto 24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jignesh Patel, MD

jignesh.patel@stonybrookmedicine.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jignesh K Patel, MD

Organizational Affiliation

Stony Brook University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stony Brook University

City

S. Setauket

State/Province

New York

ZIP/Postal Code

11720

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jignesh K Patel, MD

jignesh.patel@stonybrookmedicine.edu

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34229057

Citation

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.

Results Reference

derived

PubMed Identifier

33769417

Citation

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.

Results Reference

derived

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Improving Outcomes in Cardiac Arrest With Inhaled Nitric Oxide

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