Severe ARDS: Generating Evidence (SAGE)
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| ClinicalTrials.gov Identifier: NCT03021824 |
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Recruitment Status :
Completed
First Posted : January 16, 2017
Last Update Posted : January 28, 2020
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Sponsor:
Montefiore Medical Center
Collaborators:
University of Michigan
Duke University
University of California, Los Angeles
Information provided by (Responsible Party):
Montefiore Medical Center
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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 |
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| Acute Respiratory Distress Syndrome Acute Respiratory Failure With Hypoxia Acute Respiratory Failure |
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 |
| 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 : | October 1, 2016 |
| Actual Primary Completion Date : | April 30, 2017 |
| Actual Study Completion Date : | April 30, 2017 |
Resource links provided by the National Library of Medicine
| Group/Cohort |
|---|
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Moderate-Severe ARDS
All adults admitted to participating ICUs with study-defined moderate-to-severe ARDS.
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Primary Outcome Measures :
- Hospital Mortality [ Time Frame: 28 Days ]
- Use of Adjunctive Therapy [ Time Frame: 28 Days ]
Secondary Outcome Measures :
- Ventilator-Free Days [ Time Frame: 28 Days ]
- ICU-Free Days [ Time Frame: 28 Days ]
- Organ Failure [ Time Frame: 7 Days ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
All adults admitted to participating ICUs with study-defined moderate-to-severe ARDS.
Criteria
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
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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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03021824
Locations
Show 28 study locations
Sponsors and Collaborators
Montefiore Medical Center
University of Michigan
Duke University
University of California, Los Angeles
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Montefiore Medical Center |
| ClinicalTrials.gov Identifier: | NCT03021824 |
| Other Study ID Numbers: |
2016-6757 |
| First Posted: | January 16, 2017 Key Record Dates |
| Last Update Posted: | January 28, 2020 |
| Last Verified: | December 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
Keywords provided by Montefiore Medical Center:
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Acute Respiratory Distress Syndrome ARDS Acute Lung Injury ALI Mechanical Ventilation Extracorporeal Membrane Oxygenation |
Neuromuscular Blockade Vasodilator Agents Prone Position ECMO Acute Respiratory Failure |
Additional relevant MeSH terms:
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Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Respiratory Insufficiency Acute Lung Injury Hypoxia Lung Diseases |
Respiratory Tract Diseases Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Signs and Symptoms, Respiratory Lung Injury |