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RecruitingARDSSepsisPneumonia

The APS Phenotyping Study

Eligible age

18+ yrs

Accepts

All genders

Locations

11 states

Healthy volunteers

No

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About this 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.

Sponsor: Vanderbilt University Medical Center

You may qualify if…

  • 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:

You may not qualify if…

  • 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.

Where it's recruiting

California

Fresno · Palo Alto · San Francisco

Colorado

Denver · Loveland

Illinois

Chicago

Maryland

Baltimore

Michigan

Ann Arbor

Missouri

St Louis

Ohio

Cincinnati

Pennsylvania

Philadelphia

Tennessee

Nashville

Utah

Murray · Salt Lake City

Source: ClinicalTrials.gov · NCT06521502 · last updated 2026-02-20