Acute Respiratory Distress SyndromeSAGENCT03021824
Severe ARDS: Generating Evidence
An observational study of Acute Respiratory Distress Syndrome and Acute Respiratory Failure With Hypoxia, run by Montefiore Medical Center at 28 sites in United States.
Trial summary
An assessment of early management of moderate-severe ARDS in the United States, including ventilator management and use of rescue therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Acute Respiratory Failure With Hypoxia, Acute Respiratory Failure
- How many people
- 2,400 participants
- Where
- 28 sitesUnited States
- Study dates
- 1 Oct 2016to 30 Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adults admitted to participating ICUs with study-defined moderate-to-severe ARDS.
Who may be able to join
- 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
Who cannot join
- There are no exclusion criteria.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
Emory University
Atlanta, Georgia, 30322
Saint Agnes Hospital
Baltimore, Maryland, 21229
Johns Hopkins University
Baltimore, Maryland, 21287
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
Cleveland Clinic
Cleveland, Ohio, 44195
Ohio State University Medical Center
Columbus, Ohio, 43210
Duke University Medical Center
Durham, North Carolina, 27710
East Carolina University
Greenville, North Carolina, 27834
Mayo Clinic
Jacksonville, Florida, 32224
University of Kentucky Medical Center
Lexington, Kentucky, 40536
Los Angeles County + University of Southern California Medical Center
Los Angeles, California, 90033
University of California, Los Angeles
Los Angeles, California, 90095
Northwell Health
Manhasset, New York, 11030
Intermountain Medical Center
Murray, Utah, 84107
Columbia University Medical Center
New York, New York, 10032
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Oregan Health and Science University Hospital
Portland, Oregon, 97239
Mayo Clinic
Rochester, Minnesota, 55905
Regions Hospital
Saint Paul, Minnesota, 55101
University of Utah Hospital
Salt Lake City, Utah, 84132
Harborview Medical Center
Seattle, Washington, 98104
Baystate Medical Center
Springfield, Massachusetts, 01199
Montefiore Medical Center
The Bronx, New York, 10467
University of Arizona
Tucson, Arizona, 85721
Saint Joseph Mercy Ann Arbor
Ypsilanti, Michigan, 48197
About this study
Official title: 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.
Read the 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
- 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
- Medical subject headings
- Respiratory Distress Syndrome, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Moderate-Severe ARDS | All adults admitted to participating ICUs with study-defined moderate-to-severe ARDS. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Mortality
Measured: 28 Days
Use of Adjunctive Therapy
Measured: 28 Days
Secondary outcomes (3)
Ventilator-Free Days
Measured: 28 Days
ICU-Free Days
Measured: 28 Days
Organ Failure
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study start1 Oct 2016
- Primary completion30 Apr 2017
- Study completion30 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nida Qadir, MD, Principal investigator, Montefiore Medical CenterPauline Park, MD, Principal investigator, University of MichiganRaquel Bartz, MD, Principal investigator, Duke UniversityMichelle N Gong, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03021824
- Sponsor's protocol ID
- 2016-6757
- Acronym
- SAGE
- Status last verified
- Dec 2019
- First submitted
- 12 Jan 2017
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
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.
PubMed 34089739
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Severe ARDS: Generating Evidence. A U.S. Multicenter Observational Study.
- ClinicalTrials.gov ID
- NCT03021824
- Acronym / sponsor ID
- SAGE / 2016-6757
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,400 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- University of Michigan, Duke University, University of California, Los Angeles
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 16 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moderate-Severe ARDS | – | –All adults admitted to participating ICUs with study-defined moderate-to-severe ARDS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adults admitted to participating ICUs with study-defined moderate-to-severe ARDS.
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (1 listed)
- There are no exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hospital Mortality
Time frame: 28 Days
Use of Adjunctive Therapy
Time frame: 28 Days
3 secondary outcomes
Ventilator-Free Days
Time frame: 28 Days
ICU-Free Days
Time frame: 28 Days
Organ Failure
Time frame: 7 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Derived from this study: PubMed 34089739Qadir 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nida Qadir, MD principal investigator
Montefiore Medical Center
Pauline Park, MD principal investigator
University of Michigan
Raquel Bartz, MD principal investigator
Duke University
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome and Acute Respiratory Failure With Hypoxia, run by Montefiore Medical Center at 28 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Mortality (time frame: 28 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03021824, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2020.