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Completed

NCT Number: NCT03021824

Severe ARDS: Generating Evidence

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Arizona, Tucson, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Hospital Mortality

    Time frame: 28 Days

  2. Use of Adjunctive Therapy

    Time frame: 28 Days

Secondary outcomes

  1. Ventilator-Free Days

    Time frame: 28 Days

  2. ICU-Free Days

    Time frame: 28 Days

  3. Organ Failure

    Time frame: 7 Days

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Collaborators

  • Duke University
  • University of California, Los Angeles
  • University of Michigan

Registry information

Official study title

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

Acronym: SAGE

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 16, 2017
Registry last updated
Jan 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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