SAGE: Severe ARDS: Generating Evidence

Sponsor

Montefiore Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT03021824

Collaborator

University of Michigan (Other), Duke University (Other), University of California, Los Angeles (Other)

2,400

Enrollment

Locations

6.9

Actual Duration (Months)

85.7

Patients Per Site

12.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Distress Syndrome Acute Respiratory Failure With Hypoxia Acute Respiratory Failure

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 Design

Study Type:

Observational

Actual Enrollment :

2400 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

Oct 1, 2016

Actual Primary Completion Date :

Apr 30, 2017

Actual Study Completion Date :

Apr 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Moderate-Severe ARDS All adults admitted to participating ICUs with study-defined moderate-to-severe ARDS.

Outcome Measures

Primary Outcome Measures

Hospital Mortality [28 Days]
Use of Adjunctive Therapy [28 Days]

Secondary Outcome Measures

Ventilator-Free Days [28 Days]
ICU-Free Days [28 Days]
Organ Failure [7 Days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age > 18 years
Patients with acute respiratory failure requiring invasive mechanical ventilation via an endotracheal tube or tracheostomy with current or planned admission to the ICU
Moderate-severe ARDS as defined by fulfillment of all of the following within 48 hours:
Bilateral opacities detected on chest radiograph or CT, not fully explained by effusions, lung collapse, or nodules
Respiratory failure not fully explained by cardiac failure or fluid overload
PaO2/FiO2 ratio < 150 with a minimum of 5 cmH20 PEEP

Exclusion Criteria:

There are no exclusion criteria.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arizona	Tucson	Arizona	United States	85721
2	Los Angeles County + University of Southern California Medical Center	Los Angeles	California	United States	90033
3	University of California, Los Angeles	Los Angeles	California	United States	90095
4	Mayo Clinic	Jacksonville	Florida	United States	32224
5	Emory University	Atlanta	Georgia	United States	30322
6	University of Kentucky Medical Center	Lexington	Kentucky	United States	40536
7	Saint Agnes Hospital	Baltimore	Maryland	United States	21229
8	Johns Hopkins University	Baltimore	Maryland	United States	21287
9	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
10	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
11	Baystate Medical Center	Springfield	Massachusetts	United States	01199
12	University of Michigan Medical Center	Ann Arbor	Michigan	United States	48109
13	Saint Joseph Mercy Ann Arbor	Ypsilanti	Michigan	United States	48197
14	Mayo Clinic	Rochester	Minnesota	United States	55905
15	Regions Hospital	Saint Paul	Minnesota	United States	55101
16	Montefiore Medical Center	Bronx	New York	United States	10467
17	Northwell Health	Manhasset	New York	United States	11030
18	Columbia University Medical Center	New York	New York	United States	10032
19	Duke University Medical Center	Durham	North Carolina	United States	27710
20	East Carolina University	Greenville	North Carolina	United States	27834
21	University of Cincinnati Medical Center	Cincinnati	Ohio	United States	45219
22	Cleveland Clinic	Cleveland	Ohio	United States	44195
23	Ohio State University Medical Center	Columbus	Ohio	United States	43210
24	Oregan Health and Science University Hospital	Portland	Oregon	United States	97239
25	Temple University Hospital	Philadelphia	Pennsylvania	United States	19140
26	Intermountain Medical Center	Murray	Utah	United States	84107
27	University of Utah Hospital	Salt Lake City	Utah	United States	84132
28	Harborview Medical Center	Seattle	Washington	United States	98104