Severe ARDS: Generating Evidence
SAGE
1 other identifier
observational
2,400
1 country
28
Brief Summary
An assessment of early management of moderate-severe ARDS in the United States, including ventilator management and use of rescue therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2016
Shorter than P25 for all trials
28 active sites
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
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 12, 2017
CompletedFirst Posted
Study publicly available on registry
January 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2017
CompletedJanuary 28, 2020
December 1, 2019
7 months
January 12, 2017
January 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Hospital Mortality
28 Days
Use of Adjunctive Therapy
28 Days
Secondary Outcomes (3)
Ventilator-Free Days
28 Days
ICU-Free Days
28 Days
Organ Failure
7 Days
Study Arms (1)
Moderate-Severe ARDS
All adults admitted to participating ICUs with study-defined moderate-to-severe ARDS.
Eligibility Criteria
All adults admitted to participating ICUs with study-defined moderate-to-severe ARDS.
You may qualify if:
- Age \> 18 years
- Patients with acute respiratory failure requiring invasive mechanical ventilation via an endotracheal tube or tracheostomy with current or planned admission to the ICU
- Moderate-severe ARDS as defined by fulfillment of all of the following within 48 hours:
- Bilateral opacities detected on chest radiograph or CT, not fully explained by effusions, lung collapse, or nodules
- Respiratory failure not fully explained by cardiac failure or fluid overload
- PaO2/FiO2 ratio \< 150 with a minimum of 5 cmH20 PEEP
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Montefiore Medical Centerlead
- University of Michigancollaborator
- Duke Universitycollaborator
- University of California, Los Angelescollaborator
Study Sites (28)
University of Arizona
Tucson, Arizona, 85721, United States
Los Angeles County + University of Southern California Medical Center
Los Angeles, California, 90033, United States
University of California, Los Angeles
Los Angeles, California, 90095, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Emory University
Atlanta, Georgia, 30322, United States
University of Kentucky Medical Center
Lexington, Kentucky, 40536, United States
Saint Agnes Hospital
Baltimore, Maryland, 21229, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
University of Michigan Medical Center
Ann Arbor, Michigan, 48109, United States
Saint Joseph Mercy Ann Arbor
Ypsilanti, Michigan, 48197, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
Northwell Health
Manhasset, New York, 11030, United States
Columbia University Medical Center
New York, New York, 10032, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
East Carolina University
Greenville, North Carolina, 27834, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Oregan Health and Science University Hospital
Portland, Oregon, 97239, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
University of Utah Hospital
Salt Lake City, Utah, 84132, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
Related Publications (1)
Qadir N, Bartz RR, Cooter ML, Hough CL, Lanspa MJ, Banner-Goodspeed VM, Chen JT, Giovanni S, Gomaa D, Sjoding MW, Hajizadeh N, Komisarow J, Duggal A, Khanna AK, Kashyap R, Khan A, Chang SY, Tonna JE, Anderson HL 3rd, Liebler JM, Mosier JM, Morris PE, Genthon A, Louh IK, Tidswell M, Stephens RS, Esper AM, Dries DJ, Martinez A, Schreyer KE, Bender W, Tiwari A, Guru PK, Hanna S, Gong MN, Park PK; Severe ARDS: Generating Evidence (SAGE) Study Investigators; Society of Critical Care Medicine's Discovery Network. Variation in Early Management Practices in Moderate-to-Severe ARDS in the United States: The Severe ARDS: Generating Evidence Study. Chest. 2021 Oct;160(4):1304-1315. doi: 10.1016/j.chest.2021.05.047. Epub 2021 Jun 4.
PMID: 34089739DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nida Qadir, MD
Montefiore Medical Center
- PRINCIPAL INVESTIGATOR
Pauline Park, MD
University of Michigan
- PRINCIPAL INVESTIGATOR
Raquel Bartz, MD
Duke University
- PRINCIPAL INVESTIGATOR
Michelle N Gong, MD
Montefiore Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2017
First Posted
January 16, 2017
Study Start
October 1, 2016
Primary Completion
April 30, 2017
Study Completion
April 30, 2017
Last Updated
January 28, 2020
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will share