The ARDS, Pneumonia, and Sepsis (APS) Consortium: A Prospective Observational Study to Evaluate Phenotypes
The goal of the observational APS phenotyping study is to better understand risk factors, potential biomarkers, length and severity of illness, and recovery for adults with ARDS, pneumonia, and/ or sepsis. This study will also generate a biobank of specimens collected from these patients that will be available to investigators for future studies of ARDS, sepsis, and/or pneumonia.
⁃ To be eligible for enrollment, a patient must meet all the following inclusion criteria at the time of the first study-specified biospecimen collection (Time 0):
• Age ≥ 18 years old
• Admitted (or planned to be admitted) to an intensive care unit (ICU) or other in-patient hospital location where IV vasopressors or advanced respiratory support (invasive mechanical ventilation, non-invasive ventilation, or high flow nasal cannula) are routinely provided (referred to as an eligible unit.)
• Acute cardiovascular or pulmonary organ dysfunction defined by meeting at least one of the two criteria below:
‣ New receipt of invasive mechanical ventilation, non-invasive ventilation, high flow nasal cannula, or supplemental oxygen at a flow rate of ≥ 6 lpm for acute hypoxemia.
‣ a. Patients who use chronic oxygen therapy are eligible to participate if they are receiving at least 6 lpm higher than their baseline oxygen requirement (e.g., a patient on 3 lpm O2 at baseline is eligible if they require ≥9 lpm for hypoxemia) or are started on advanced respiratory support (invasive mechanical ventilation, non- invasive ventilation, or high flow nasal cannula).
⁃ Receipt of intravenous infusion of a vasopressor medication for at least one hour.
• Acute cardiovascular or pulmonary organ dysfunction (inclusion criterion #3) is attributed to an acute inflammatory condition, including but not limited to any of the following:
‣ Any infection including pneumonia.
⁃ Aspiration pneumonitis.
⁃ Pancreatitis.
⁃ Auto-inflammatory condition such as:
• Hemophagocytic lymphohistiocytosis.
∙ Suspected acute rheumatologic or auto-immune disease with pulmonary or cardiovascular manifestations.
∙ Suspected cryptogenic organizing pneumonia presenting acutely.
∙ Suspected diffuse alveolar hemorrhage.
∙ Suspected acute anaphylaxis.
∙ Suspected acute pulmonary drug toxicity.