Severe ARDS: Generating Evidence (SAGE)

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

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

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 2400

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85721
      • University of Arizona
  • California
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles
    • Los Angeles, California, United States, 90033
      • Los Angeles County + University of Southern California Medical Center
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University
    • Baltimore, Maryland, United States, 21229
      • Saint Agnes Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Springfield, Massachusetts, United States, 01199
      • Baystate Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Medical Center
    • Ypsilanti, Michigan, United States, 48197
      • Saint Joseph Mercy Ann Arbor
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
    • Saint Paul, Minnesota, United States, 55101
      • Regions Hospital
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • Manhasset, New York, United States, 11030
      • Northwell Health
    • New York, New York, United States, 10032
      • Columbia University Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Greenville, North Carolina, United States, 27834
      • East Carolina University
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati Medical Center
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43210
      • Ohio State University Medical Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregan Health and Science University Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Hospital
  • Washington
    • Seattle, Washington, United States, 98104
      • Harborview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Moderate-Severe ARDS; All adults admitted to participating ICUs with study-defined moderate-to-severe ARDS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hospital Mortality	28 Days
Use of Adjunctive Therapy	28 Days

Secondary Outcome Measures

Outcome Measure	Time Frame
Ventilator-Free Days	28 Days
ICU-Free Days	28 Days
Organ Failure	7 Days

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Collaborators: University of California, Los Angeles; University of Michigan; Duke University
• Investigators: Principal Investigator: Nida Qadir, MD, Montefiore Medical Center; Principal Investigator: Pauline Park, MD, University of Michigan; Principal Investigator: Raquel Bartz, MD, Duke University; Principal Investigator: Michelle N Gong, MD, Montefiore Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2016
• Primary Completion (ACTUAL): April 30, 2017
• Study Completion (ACTUAL): April 30, 2017

Study Registration Dates

• First Submitted: January 12, 2017
• First Submitted That Met QC Criteria: January 12, 2017
• First Posted (ESTIMATE): January 16, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 28, 2020
• Last Update Submitted That Met QC Criteria: January 24, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: ARDS; ECMO; Mechanical Ventilation; Prone Position; Acute Respiratory Distress Syndrome; Extracorporeal Membrane Oxygenation; Acute Lung Injury; ALI; Neuromuscular Blockade; Vasodilator Agents; Acute Respiratory Failure
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Signs and Symptoms, Respiratory; Lung Injury; Infant, Premature, Diseases; Respiratory Insufficiency; Hypoxia; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: 2016-6757

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES