An observational study in Acute Respiratory Distress Syndrome, Acute Respiratory Failure With Hypoxia and Acute Respiratory Failure, sponsored by Montefiore Medical Center. Completed at 28 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-28.
Sponsored by Montefiore Medical Center · Observational
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.
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's enrollment of 2,400 is above the median of 100 across 540 observational studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Montefiore Medical Center is the lead sponsor of 402 studies on the registry; 70 are open to participants now.
Of its 81 completed or terminated interventional studies of FDA-regulated products, 73 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
All adults admitted to participating ICUs with study-defined moderate-to-severe ARDS.
Moderate-severe ARDS as defined by fulfillment of all of the following within 48 hours:
Exclusion Criteria:
There are no exclusion criteria.
All adults admitted to participating ICUs with study-defined moderate-to-severe ARDS.
Hospital Mortality
Time frame: 28 Days
Use of Adjunctive Therapy
Time frame: 28 Days
Ventilator-Free Days
Time frame: 28 Days
ICU-Free Days
Time frame: 28 Days
Organ Failure
Time frame: 7 Days
Plan to share: Yes
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Respiratory Distress Syndrome→
Montefiore Medical Center