NCT03021824

Severe ARDS: Generating Evidence

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,400 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Respiratory Distress Syndrome
• Acute Respiratory Failure With Hypoxia
• Acute Respiratory Failure

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-04-30
• Completion: 2017-04-30
• First posted: 2017-01-16
• Last updated: 2020-01-28

Locations

28 sites across 1 country: United States