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Understanding risk factors and biomarkers in ARDS, sepsis, and pneumonia

The ARDS, Pneumonia, and Sepsis (APS) Consortium: A Prospective Observational Study to Evaluate Phenotypes

Observational Vanderbilt University Medical Center · NCT06521502

This study is trying to find out what causes acute respiratory distress syndrome, sepsis, and pneumonia by collecting health information and samples from hospitalized adults to help improve treatment for these conditions.

Quick facts

Study typeObservational
Enrollment4000 (estimated)
Ages18 Years and up
SexAll
SponsorVanderbilt University Medical Center Academic / other
Drugs / interventionschemotherapy
Locations20 sites (Fresno, California and 19 other locations)
Trial IDNCT06521502 on ClinicalTrials.gov

What this trial studies

The APS phenotyping study aims to gather detailed clinical data and biological samples from hospitalized adults who have or are at risk of developing acute respiratory distress syndrome (ARDS), sepsis, or pneumonia. Participants will undergo various assessments, including questionnaires and collection of blood, urine, and stool samples, to identify potential biomarkers and risk factors associated with these conditions. The study will also create a biobank for future research, focusing on classifying patients into biologically relevant phenotype categories to enhance understanding and treatment of these illnesses.

Who should consider this trial

Good fit: Ideal candidates for this study are hospitalized adults aged 18 and older who are admitted to an ICU or similar unit and exhibit acute cardiovascular or pulmonary dysfunction.

Not a fit: Patients who are not hospitalized or do not exhibit acute organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved identification and treatment strategies for patients suffering from ARDS, sepsis, and pneumonia.

How similar studies have performed: Other studies focusing on phenotyping and biomarker identification in similar conditions have shown promise, indicating a potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Fresno, California and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions ARDSSepsisPneumoniaacute respiratory distress syndromesepsispneumoniaphenotypeendotype
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.