REASON 1 Trial: Sonography in Cardiac Arrest

This study is currently recruiting participants.

Verified April 2013 by University of Massachusetts, Worcester

Sponsor:

Collaborators:

North Shore University Hospital

New York University School of Medicine

Mount Sinai Hospital, New York

Washington University School of Medicine

University of New Mexico

Advocate Health Care

University of California, Irvine

University of Utah

Carolinas Medical Center

Emory University

Louisiana State University Health Sciences Center in New Orleans

Duke University

Brigham and Women's Hospital

Massachusetts General Hospital

Rhode Island Hospital

Christiana Care Health Services

George Washington University

Kingston General Hospital

University of Ottawa

Jewish General Hospital

Horizon Health Network, Saint John Zone

York Hospitals

Boston Medical Center

Indiana University

Yale University

Queen's Medical Centre

University of Hawaii

Stanford University

Information provided by (Responsible Party):

Romolo Gaspari, University of Massachusetts, Worcester

ClinicalTrials.gov Identifier:

NCT01446471

First received: September 9, 2011

Last updated: April 10, 2013

Last verified: April 2013

History of Changes

Purpose

The aim of this study is to investigate the predictive value of the presence or absence of cardiac activity by bedside ultrasound during cardiac arrest. The investigators anticipate based on previous research that patients who suffer a cardiac arrest and have cardiac activity on bedside ultrasound will have a greater chance of surviving to hospital admission. The investigators hypothesis is that the mortality rate in patients in cardiac arrest with no cardiac activity by ultrasound will have a mortality rate of 100%.

Condition
Cardiac Arrest Pulseless Electrical Activity Asystole

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	REASON 1 Trial: Sonography in Cardiac Arrest

Resource links provided by NLM:

MedlinePlus related topics: Cardiac Arrest

U.S. FDA Resources

Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:

Number of patients that survive to Hospital Discharge [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
Participants will be followed for the duration of hospital stay, an expected average of up to 12 months. The time frame is an estimate based on previous research. Patients could survive hours to days to weeks or months.

Secondary Outcome Measures:

The number of patients that demonstrate a Return of Spontaneous Circulation [ Time Frame: Up to 60 Minutes - ] [ Designated as safety issue: No ]
Participants will be followed until a demonstrated return of spontaneous circulation (i.e. regain a pulse and blood pressure) is present - an expected average of up to 60 minutes. The time frame is an estimate based on previous research but is in the order of minutes.
The number of patients that survive to hospital admission [ Time Frame: Up to 24 hours ] [ Designated as safety issue: No ]
Surviving participants will be followed to hospital admission- an expected average of up to 24 hours. The time frame is an estimate based on previous research. Patients could survive minutes to hours before they are admitted.

Estimated Enrollment:	1000
Study Start Date:	January 2010
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	June 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts
Cardiac Arrest Patients in Cardiac Arrest will be enrolled

Show Detailed Description

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients in cardiac arrest

Criteria

Inclusion Criteria:

Patients in cardiac arrest with no pulse

Exclusion Criteria:

Patients with isolated ventricular fibrillation as their cardiac rhythm at the time of presentation
Traumatic cardiopulmonary arrest
Ultrasound system or physician experienced in bedside cardiac ultrasound not available
Resuscitative efforts halted due to end of life decisions or designations
Attending physician of record declines enrollment of patient

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01446471

Contacts

Contact: Romolo Gaspari, MD, PhD

508-334-7943

romolo.gaspari@umassmemorial.org

Locations

United States, Delaware
Christiana Health Care	Recruiting
Newark, Delaware, United States
Contact: Jason Nomura, MD jnomura@comcast.net
Principal Investigator: Jason Nomura, MD
United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States
Contact: Vicki Nobel, MD vnoble@partners.org
Principal Investigator: Vicki Noble, MD
UMASS Memorial Medical Center	Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Virginia Mangolds, NP 508-421-1400 virginia.mangolds@umassmemorial.org
Principal Investigator: Romolo Gaspari, MD, PhD
United States, Missouri
Washington University Hospital	Recruiting
St Louis, Missouri, United States
Contact: Dan Theodoro, MD theodorod@wusm.wustl.edu
Principal Investigator: Dan Theodoro, MD
United States, New York
Northshore University Hospital	Recruiting
Manhasset, New York, United States
Contact: Chris Raio, MD Craio7@gmail.com
Principal Investigator: Christopher Raio, MD
United States, North Carolina
Carolinas Medical Center	Recruiting
Charlotte, North Carolina, United States
Contact: Anthony Weekes, MD anthony.weekes@carolinashealthcare.org
Principal Investigator: Anthony Weekes, MD
Canada
University of Ottowa	Recruiting
Ottowa, Canada
Contact: Micheal Woo, MD mwoo@ottawahospital.on.ca
Principal Investigator: Michael Woo

Sponsors and Collaborators

University of Massachusetts, Worcester