Status:
RECRUITING
The APS Phenotyping Study
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
ARDS
Sepsis
Eligibility:
All Genders
18+ years
Brief 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 se...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 25 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 30 2028
Estimated Enrollment :
4000 Patients enrolled
Trial Details
Trial ID
NCT06521502
Start Date
July 25 2024
End Date
April 30 2028
Last Update
September 10 2025
Active Locations (18)
Enter a location and click search to find clinical trials sorted by distance.
1
Fresno Community Hospital and Medical Center
Fresno, California, United States, 93721
2
Stanford University
Palo Alto, California, United States, 94305
3
San Francisco General Hospital
San Francisco, California, United States, 94110
4
University of California, San Francisco
San Francisco, California, United States, 94143