The ARDS, Pneumonia, and Sepsis (APS) Consortium: A Prospective Observational Study to Evaluate Phenotypes
Vanderbilt University Medical Center
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.
Description
The APS phenotyping study will enroll hospitalized adult patients ≥18 years old who have or are at risk of developing ARDS, sepsis, or pneumonia. Participation in this study will involve collection of clinical data, completing questionnaires, and collection of samples such as blood, urine, and stool. Participants who are mechanically ventilated will also provide samples from their respiratory track. Data and samples will be collected both during and after hospitalization. Analyses to understand the mechanisms underlying ARDS, pneumonia, and sepsis will be conducted, with goals including the cl…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- OtherBlood collection
Blood will be collected from a catheter ("IV") that is already in place or using a needle stick into a vein. Blood will be collected in hospital (Cohorts A, B) and at visits 3 and 12 months following hospitalization for (Long-term Outcomes Cohort).
- OtherUrine Collection
Urine will be collected through a urinary catheter that is already in place or by urinating into a cup. Urine will be collected in hospital only (Cohorts A, B)
- OtherNasal, oral, and rectal swabs
Nasal, oral, and rectal swabs inserted into the nose, mouth, and rectum, respectively. The swabs will be rubbed inside the cavity and then removed the swab. Oral and nasal swabs will also be collected in hospital (Cohort A, B) and at visits 3 and 12 months following hospitalization for (Long-term Outcomes Cohort). Rectal swabs will be collected in hospital only (Cohorts A, B).
- OtherStool collection
Stool will be collected either in a cup after defecation or by collecting it from a tube or bag that may already be in place that is catching stool. Stool will be collected in hospital (Cohorts A, B) and at visits 3 and 12 months following hospitalization (Long Term Outcomes Cohort).
- OtherHeat Moisture Exchange Filter collection
Locations (20)
- Fresno Community Hospital and Medical CenterFresno, California
- Stanford UniversityPalo Alto, California
- San Francisco General HospitalSan Francisco, California
- University of California, San FranciscoSan Francisco, California
- University of Colorado, DenverDenver, Colorado
- Denver Health and Hospital AuthorityDenver, Colorado