Severe ARDS: Generating Evidence

NCT ID: NCT03021824

Last Updated: 2020-01-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-01
• Study Completion Date: 2017-04-30

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.

Conditions

Acute Respiratory Distress Syndrome; Acute Respiratory Failure With Hypoxia; Acute Respiratory Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Moderate-Severe ARDS

All adults admitted to participating ICUs with study-defined moderate-to-severe ARDS.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: collaborator

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nida Qadir, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Pauline Park, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Raquel Bartz, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Michelle N Gong, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

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

Jacksonville, Florida, United States

Emory University

Atlanta, Georgia, United States

University of Kentucky Medical Center

Lexington, Kentucky, United States

Saint Agnes Hospital

Baltimore, Maryland, United States

Johns Hopkins University

Baltimore, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Baystate Medical Center

Springfield, Massachusetts, United States

University of Michigan Medical Center

Ann Arbor, Michigan, United States

Saint Joseph Mercy Ann Arbor

Ypsilanti, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Regions Hospital

Saint Paul, Minnesota, United States

Northwell Health

Manhasset, New York, United States

Columbia University Medical Center

New York, New York, United States

Montefiore Medical Center

The Bronx, 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

Cleveland Clinic

Cleveland, Ohio, United States

Ohio State University Medical Center

Columbus, Ohio, United States

Oregan Health and Science University Hospital

Portland, Oregon, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

Intermountain Medical Center

Murray, Utah, United States

University of Utah Hospital

Salt Lake City, Utah, United States

Harborview Medical Center

Seattle, Washington, United States

Countries

United States

References

Qadir N, Bartz RR, Cooter ML, Hough CL, Lanspa MJ, Banner-Goodspeed VM, Chen JT, Giovanni S, Gomaa D, Sjoding MW, Hajizadeh N, Komisarow J, Duggal A, Khanna AK, Kashyap R, Khan A, Chang SY, Tonna JE, Anderson HL 3rd, Liebler JM, Mosier JM, Morris PE, Genthon A, Louh IK, Tidswell M, Stephens RS, Esper AM, Dries DJ, Martinez A, Schreyer KE, Bender W, Tiwari A, Guru PK, Hanna S, Gong MN, Park PK; Severe ARDS: Generating Evidence (SAGE) Study Investigators; Society of Critical Care Medicine's Discovery Network. Variation in Early Management Practices in Moderate-to-Severe ARDS in the United States: The Severe ARDS: Generating Evidence Study. Chest. 2021 Oct;160(4):1304-1315. doi: 10.1016/j.chest.2021.05.047. Epub 2021 Jun 4.

Reference Type: DERIVED

PMID: 34089739 (View on PubMed)

Other Identifiers

2016-6757

Identifier Type: -

Identifier Source: org_study_id