The APS Phenotyping Study

Recruiting

• Conditions: ARDS; Sepsis; Pneumonia

• Registration Number: NCT06521502
• Lead Sponsor: Vanderbilt University Medical Center

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 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.

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 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 classification of patients with ARDS, pneumonia, and sepsis into biologically based phenotype categories and identifying new targets for future therapeutic trials.

Study Timeline

• Study First Submitted: 2024-07-16
• Study First Submitted QC: 2024-07-20
• Study Start: 2024-07-25
• Study First Posted: 2024-07-26
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-27
• Primary Completion: 2028-04-30
• Study Completion: 2028-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ARDS, pneumonia, and sepsis classification	Through day 7	Classification of critically ill adults into disease categories based on published paradigms, including the Berlin Criteria for ARDS, Sepsis-3 criteria for sepsis, and Centers for Disease Control and Prevention (CDC) criteria for pneumonia.

Secondary Outcome Measures

Name	Time	Method
Death	28 days, 3 months, 6 months, 12 months	All-cause mortality

Trial Locations

Locations (19)

Fresno Community Hospital and Medical Center; 🇺🇸 Fresno, California, United States

Stanford University; 🇺🇸 Palo Alto, California, United States

San Francisco General Hospital; 🇺🇸 San Francisco, California, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

University of Colorado, Denver; 🇺🇸 Denver, Colorado, United States

Denver Health and Hospital Authority; 🇺🇸 Denver, Colorado, United States

National Jewish Health; 🇺🇸 Denver, Colorado, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Johns Hopkins Univeristy; 🇺🇸 Baltimore, Maryland, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

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