Severe ARDS: Generating Evidence



Status:Completed
Conditions:Hospital, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases, Other
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:October 1, 2016
End Date:April 30, 2017

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Severe ARDS: Generating Evidence. A U.S. Multicenter Observational Study.

An assessment of early management of moderate-severe ARDS in the United States, including
ventilator management and use of rescue therapy.

Approximately one-quarter of ARDS patients develop severe hypoxemia, which has been
associated with mortality rates approximating 40-50%. The majority have been described to
present with severe disease at baseline, suggesting an opportunity for early intervention. In
addition, use of evidence-based practices in severe ARDS is highly variable and inconsistent;
use of unproven treatment modalities is also frequently seen. Given the variability in
treatment practices in severe ARDS, an understanding of the patient-level and
institutional-level factors contributing to differences in therapeutic approach is needed in
order to improve the quality and consistency of care given to these high-risk patients. SAGE
is a multicenter, observational cohort study examining the patient-level and institutional
characteristics associated with variability in management of patients with moderate to severe
ARDS, factors associated with survival or need for adjuvant therapy, and variability in
ventilator management of patients on extracorporeal membrane oxygenation. Findings from this
observational study can subsequently be used to inform future interventional trial
development.

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.
We found this trial at
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Manhasset, New York 11030
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75 Francis street
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330 Brookline Ave
Boston, Massachusetts 02215
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3550 Jerome Avenue
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234 Goodman Dr
Cincinnati, Ohio 45229
(513) 584-1000
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9500 Euclid Avenue
Cleveland, Ohio 44106
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4201 Belfort Road
Jacksonville, Florida 32216
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740 South Limestone Street
Lexington, Kentucky 40536
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Los Angeles, California 90095
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Ann Arbor, Michigan 48109
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2301 Erwin Rd
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1001 E 5th St
Greenville, North Carolina 27858
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5121 S Cottonwood St
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630 W 168th St
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3401 N Broad St
Philadelphia, Pennsylvania
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Rochester, Minnesota 55905
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640 Jackson Street
Saint Paul, Minnesota 55101
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Salt Lake City, Utah 84132
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325 9th Ave
Seattle, Washington 98104
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759 Chestnut Street
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Tucson, Arizona 85721
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Ypsilanti, Michigan 48197
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