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Severe ARDS: Generating Evidence (SAGE)

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ClinicalTrials.gov Identifier: NCT03021824
Recruitment Status : Completed
First Posted : January 16, 2017
Last Update Posted : March 22, 2018
Sponsor:
Collaborators:
University of Michigan
Duke University
Information provided by (Responsible Party):
Nida Qadir, Albert Einstein College of Medicine

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
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.

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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


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



Primary Outcome Measures :
  1. Hospital Mortality [ Time Frame: 28 Days ]
  2. Use of Adjunctive Therapy [ Time Frame: 28 Days ]

Secondary Outcome Measures :
  1. Ventilator-Free Days [ Time Frame: 28 Days ]
  2. ICU-Free Days [ Time Frame: 28 Days ]
  3. Organ Failure [ Time Frame: 7 Days ]


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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:

  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.


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


  Show 28 Study Locations
Sponsors and Collaborators
Montefiore Medical Center
University of Michigan
Duke University
Investigators
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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

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Responsible Party: Nida Qadir, Assistant Professor of Medicine, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT03021824     History of Changes
Other Study ID Numbers: 2016-6757
First Posted: January 16, 2017    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Nida Qadir, Albert Einstein College of Medicine:
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, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Hypoxia
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Lung Injury