The APS Phenotyping Study

Inclusion criteria

• 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.

Exclusion criteria

• To be eligible for enrollment, a patient must not meet any of the following exclusion criteria at the time of the first study-specified biospecimen collection (Time 0):
• Patient/legally authorized representative (LAR) declines participation.
• Acute cardiovascular or pulmonary organ dysfunction (inclusion criterion #3) has been present for \> 48 hours.
• Patient has been in an eligible unit (inclusion criterion #2) for more than 120 hours (five days).
• Patient is no longer expected to meet the acute cardiovascular or pulmonary organ dysfunction inclusion criterion (inclusion criterion #3) 24 hours after enrollment.
• Patient desires comfort measures only.
• Patient is a prisoner.
• Patient had out-of-hospital cardiac arrest leading to this hospitalization.
• Residence immediately before this hospitalization in a long-term acute care facility.
• Presence of tracheostomy for respiratory failure.
• Home invasive mechanical ventilation or non-invasive ventilation (except patients with non-invasive ventilation prescribed as a treatment for a sleep disorder may participate).
• Suspected cause of the patient's acute cardiovascular and/or pulmonary dysfunction (inclusion criterion #3) is an alternative condition (not ARDS, pneumonia, or sepsis), including but not limited to the list below:
• Drug overdose (without aspiration, lung injury, pneumonia, or infection).
• Trauma (without aspiration, pneumonia, or infection).
• Chronic lung disease without suspected infection, aspiration, or inflammation.
• Asthma, chronic obstructive pulmonary disease (COPD), sarcoidosis, interstitial lung disease, neuromuscular respiratory failure.
• Status epilepticus.
• Acute pulmonary embolism.
• Acute decompensated heart failure.
• Diabetic ketoacidosis.
• Acute stroke or intracranial hemorrhage.
• Acute bleeding (GI bleeding, post-procedural bleeding, hemolysis).
• Cytokine release syndrome due to chemotherapy.
• Inability or unwillingness to complete study-specified blood draws, for example, due to local policies about hemoglobin thresholds for research blood draws.