NCT04134078

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Aug 2016

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 21, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

October 21, 2019

Status Verified

October 1, 2019

Enrollment Period

3.9 years

First QC Date

October 17, 2019

Last Update Submit

October 18, 2019

Conditions

Cardiac Arrest

Outcome Measures

Primary Outcomes (2)

  • 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

    1 day

  • 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

    1 day

Secondary Outcomes (2)

  • Neurologic outcomes at hospital discharge

    upto 24 weeks

  • short term survival

    upto 24 weeks

Study Arms (1)

inhaled nitric oxide

EXPERIMENTAL

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

Interventions

inhaled nitric oxideDRUG

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

inhaled nitric oxide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stony Brook University

South Setauket, New York, 11720, United States

RECRUITING

Related Publications (2)

  • 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.

    PMID: 34229057DERIVED

  • 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.

    PMID: 33769417DERIVED

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Jignesh K Patel, MD

    Stony Brook University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jignesh Patel, MD

CONTACT

jignesh.patel@stonybrookmedicine.edu

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

October 17, 2019

First Posted

October 21, 2019

Study Start

August 1, 2016

Primary Completion

July 1, 2020

Study Completion

July 1, 2022

Last Updated

October 21, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)