Acute Respiratory Distress Syndrome Clinical Trial
— SAGEOfficial title:
Severe ARDS: Generating Evidence. A U.S. Multicenter Observational Study.
NCT number | NCT03021824 |
Other study ID # | 2016-6757 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2016 |
Est. completion date | April 30, 2017 |
Verified date | December 2019 |
Source | Montefiore Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
An assessment of early management of moderate-severe ARDS in the United States, including ventilator management and use of rescue therapy.
Status | Completed |
Enrollment | 2400 |
Est. completion date | April 30, 2017 |
Est. primary completion date | April 30, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Age > 18 years 2. Patients with acute respiratory failure requiring invasive mechanical ventilation via an endotracheal tube or tracheostomy with current or planned admission to the ICU 3. Moderate-severe ARDS as defined by fulfillment of all of the following within 48 hours: 1. Bilateral opacities detected on chest radiograph or CT, not fully explained by effusions, lung collapse, or nodules 2. Respiratory failure not fully explained by cardiac failure or fluid overload 3. PaO2/FiO2 ratio < 150 with a minimum of 5 cmH20 PEEP Exclusion Criteria: There are no exclusion criteria. |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan Medical Center | Ann Arbor | Michigan |
United States | Emory University | Atlanta | Georgia |
United States | Johns Hopkins University | Baltimore | Maryland |
United States | Saint Agnes Hospital | Baltimore | Maryland |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Montefiore Medical Center | Bronx | New York |
United States | University of Cincinnati Medical Center | Cincinnati | Ohio |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | Ohio State University Medical Center | Columbus | Ohio |
United States | Duke University Medical Center | Durham | North Carolina |
United States | East Carolina University | Greenville | North Carolina |
United States | Mayo Clinic | Jacksonville | Florida |
United States | University of Kentucky Medical Center | Lexington | Kentucky |
United States | Los Angeles County + University of Southern California Medical Center | Los Angeles | California |
United States | University of California, Los Angeles | Los Angeles | California |
United States | Northwell Health | Manhasset | New York |
United States | Intermountain Medical Center | Murray | Utah |
United States | Columbia University Medical Center | New York | New York |
United States | Temple University Hospital | Philadelphia | Pennsylvania |
United States | Oregan Health and Science University Hospital | Portland | Oregon |
United States | Mayo Clinic | Rochester | Minnesota |
United States | Regions Hospital | Saint Paul | Minnesota |
United States | University of Utah Hospital | Salt Lake City | Utah |
United States | Harborview Medical Center | Seattle | Washington |
United States | Baystate Medical Center | Springfield | Massachusetts |
United States | University of Arizona | Tucson | Arizona |
United States | Saint Joseph Mercy Ann Arbor | Ypsilanti | Michigan |
Lead Sponsor | Collaborator |
---|---|
Montefiore Medical Center | Duke University, University of California, Los Angeles, University of Michigan |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hospital Mortality | 28 Days | ||
Primary | Use of Adjunctive Therapy | 28 Days | ||
Secondary | Ventilator-Free Days | 28 Days | ||
Secondary | ICU-Free Days | 28 Days | ||
Secondary | Organ Failure | 7 Days |
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