Severe ARDS: Generating Evidence

Acute Respiratory Distress Syndrome Clinical Trial

— SAGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03021824
• Other study ID #: 2016-6757
• Status: Completed
• Start date: October 1, 2016
• Est. completion date: April 30, 2017

Study information

• Verified date: December 2019
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Acute Respiratory Failure
• Acute Respiratory Failure With Hypoxia
• Hypoxia
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Respiratory Insufficiency

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
Montefiore Medical Center	Duke University, University of California, Los Angeles, University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

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