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The APS Phenotyping Study

RecruitingObservational study

The ARDS, Pneumonia, and Sepsis (APS) Consortium: A Prospective Observational Study to Evaluate Phenotypes

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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):

1. Age ≥ 18 years old
2. 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.")
3. 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.
4. 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:

     1. Hemophagocytic lymphohistiocytosis.
     2. Suspected acute rheumatologic or auto-immune disease with pulmonary or cardiovascular manifestations.
     3. Suspected cryptogenic organizing pneumonia presenting acutely.
     4. Suspected diffuse alveolar hemorrhage.
     5. Suspected acute anaphylaxis.
     6. 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):

1. Patient/legally authorized representative (LAR) declines participation.
2. Acute cardiovascular or pulmonary organ dysfunction (inclusion criterion #3) has been present for \> 48 hours.
3. Patient has been in an eligible unit (inclusion criterion #2) for more than 120 hours (five days).
4. Patient is no longer expected to meet the acute cardiovascular or pulmonary organ dysfunction inclusion criterion (inclusion criterion #3) 24 hours after enrollment.
5. Patient desires comfort measures only.
6. Patient is a prisoner.
7. Patient had out-of-hospital cardiac arrest leading to this hospitalization.
8. Residence immediately before this hospitalization in a long-term acute care facility.
9. Presence of tracheostomy for respiratory failure.
10. Home invasive mechanical ventilation or non-invasive ventilation (except patients with non-invasive ventilation prescribed as a treatment for a sleep disorder may participate).
11. 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.
12. Inability or unwillingness to complete study-specified blood draws, for example, due to local policies about hemoglobin thresholds for research blood draws.

About the study

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.

What is being tested

Sponsor: Vanderbilt University Medical Center · Participants: 4,000 · Started: Jul 25, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06521502

Locations in the U.S.

CaliforniaFresno Community Hospital and Medical Center, Fresno
Stanford University, Palo Alto
San Francisco General Hospital, San Francisco
University of California, San Francisco, San Francisco
ColoradoDenver Health and Hospital Authority, Denver
National Jewish Health, Denver
University of Colorado, Denver, Denver
UC Health Medical Center of the Rockies, Loveland
IllinoisNorthwestern Memorial Hospital, Chicago
University of Chicago, Chicago
MarylandJohns Hopkins Univeristy, Baltimore
MichiganUniversity of Michigan, Ann Arbor
MissouriWashington University School of Medicine, St Louis
North CarolinaDuke University, Durham
OhioUniversity of Cincinnati, Cincinnati
PennsylvaniaUniversity of Pennsylvania, Philadelphia
TennesseeMeharry Medical College, Nashville
Vanderbilt University Medical Center, Nashville
UtahIntermountain Medical Center, Murray
University of Utah, Salt Lake City

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.