The APS Phenotyping Study

Description

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.

Conditions

ARDS, Sepsis, Pneumonia

Study Overview

Study Details

Study overview

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.

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

The APS Phenotyping Study

Condition
ARDS
Intervention / Treatment

-

Contacts and Locations

Fresno

Fresno Community Hospital and Medical Center, Fresno, California, United States, 93721

Palo Alto

Stanford University, Palo Alto, California, United States, 94305

San Francisco

San Francisco General Hospital, San Francisco, California, United States, 94110

San Francisco

University of California, San Francisco, San Francisco, California, United States, 94143

Denver

University of Colorado, Denver, Denver, Colorado, United States, 80045

Denver

Denver Health and Hospital Authority, Denver, Colorado, United States, 80204

Denver

National Jewish Health, Denver, Colorado, United States, 80206

Chicago

University of Chicago, Chicago, Illinois, United States, 60637

Baltimore

Johns Hopkins Univeristy, Baltimore, Maryland, United States, 21218

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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.
  • * 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vanderbilt University Medical Center,

Wesley H. Self, MD, MPH, PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center

Study Record Dates

2028-04-30