The APS Phenotyping Study (NCT06521502) | Clinical Trial Compass
RecruitingNot Applicable
The APS Phenotyping Study
United States4,000 participantsStarted 2024-07-25
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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:
✓. 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:
✓. Hemophagocytic lymphohistiocytosis.
✓. Suspected acute rheumatologic or auto-immune disease with pulmonary or cardiovascular manifestations.
. 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.