Severe ARDS: Generating Evidence

Completed

• Conditions: Acute Respiratory Failure; Acute Respiratory Failure With Hypoxia; Acute Respiratory Distress Syndrome

• Registration Number: NCT03021824
• Lead Sponsor: Montefiore Medical Center

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2016-10-01
• Study First Submitted: 2017-01-12
• Study First Submitted QC: 2017-01-12
• Study First Posted: 2017-01-16
• Primary Completion: 2017-04-30
• Study Completion: 2017-04-30
• Status Verified: 2019-12
• Last Update Submitted: 2020-01-24
• Last Update Posted: 2020-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hospital Mortality	28 Days
Use of Adjunctive Therapy	28 Days

Secondary Outcome Measures

Name	Time	Method
ICU-Free Days	28 Days
Ventilator-Free Days	28 Days
Organ Failure	7 Days

Trial Locations

Locations (27)

University of Arizona; 🇺🇸 Tucson, Arizona, 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

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

University of Kentucky Medical Center; 🇺🇸 Lexington, Kentucky, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Saint Agnes Hospital; 🇺🇸 Baltimore, Maryland, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

University of Michigan Medical Center; 🇺🇸 Ann Arbor, Michigan, United States

Baystate Medical Center; 🇺🇸 Springfield, Massachusetts, United States

Regions Hospital; 🇺🇸 Saint Paul, Minnesota, United States

Saint Joseph Mercy Ann Arbor; 🇺🇸 Ypsilanti, Michigan, United States

Northwell Health; 🇺🇸 Manhasset, New York, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

East Carolina University; 🇺🇸 Greenville, North Carolina, United States

University of Cincinnati Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Oregan Health and Science University Hospital; 🇺🇸 Portland, Oregon, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Temple University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Intermountain Medical Center; 🇺🇸 Murray, Utah, United States

Harborview Medical Center; 🇺🇸 Seattle, Washington, United States

University of Utah Hospital; 🇺🇸 Salt Lake City, Utah, United States

Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States