Clinical trial NCT03021824: Severe ARDS: Generating Evidence
Official title: Severe ARDS: Generating Evidence. A U.S. Multicenter Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Distress Syndrome
Acute Respiratory Failure With Hypoxia
Acute Respiratory Failure
Keywords: Acute Respiratory Distress Syndrome
ARDS
Acute Lung Injury
ALI
Mechanical Ventilation
Extracorporeal Membrane Oxygenation
Neuromuscular Blockade
Vasodilator Agents
Prone Position
ECMO
Acute Respiratory Failure
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: Duke University
name: University of California, Los Angeles
First posted: 2017-01-16
Enrollment: 2400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adults admitted to participating ICUs with study-defined moderate-to-severe ARDS.

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.

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

Exclusion Criteria:

There are no exclusion criteria.

Primary outcomes:
measure: Hospital Mortality
timeFrame: 28 Days
measure: Use of Adjunctive Therapy
timeFrame: 28 Days
Secondary outcomes:
measure: Ventilator-Free Days
timeFrame: 28 Days
measure: ICU-Free Days
timeFrame: 28 Days
measure: Organ Failure
timeFrame: 7 Days
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Los Angeles
country: United States
facility: Los Angeles County + University of Southern California Medical Center
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
city: Baltimore
country: United States
facility: Saint Agnes Hospital
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
city: Ypsilanti
country: United States
facility: Saint Joseph Mercy Ann Arbor
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Manhasset
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Portland
country: United States
facility: Oregan Health and Science University Hospital
state: Oregon
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
affiliation: Montefiore Medical Center
name: Nida Qadir, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Pauline Park, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Raquel Bartz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Montefiore Medical Center
name: Michelle N Gong, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.