The APS Phenotyping Study
The ARDS, Pneumonia, and Sepsis (APS) Consortium: A Prospective Observational Study to Evaluate Phenotypes
1 other identifier
observational
4,000
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2024
Longer than P75 for all trials
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2024
CompletedStudy Start
First participant enrolled
July 25, 2024
CompletedFirst Posted
Study publicly available on registry
July 26, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2029
February 20, 2026
February 1, 2026
4.8 years
July 16, 2024
February 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ARDS, pneumonia, and sepsis classification
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.
Through day 7
Secondary Outcomes (1)
Death
28 days, 3 months, 12 months
Other Outcomes (28)
Invasive ventilator free days
In-hospital through day 28
Ventilatory support free days
In-hospital through day 28
Vasopressor free days
In-hospital through day 28
- +25 more other outcomes
Study Arms (3)
Cohort A (full study protocol - written informed consent)
Cohort A is the cohort of APS study participants who have provided written informed consent for participation in the APS phenotyping study. Cohort A may participate in all study procedures in the APS phenotyping study.
Cohort B (alteration study protocol - alteration of informed consent)
Cohort B is the cohort of APS study participants who are enrolled in the study under alteration of informed consent. Cohort B will participate in a modified set of procedures which omits procedures considered greater than minimal risk.
Long-term Outcomes Cohort
The Long-term Outcomes Cohort consists of a subset of participants with written informed consent for study participation (Cohort A) who complete in-person post-hospital study assessments. These in-person study visits are scheduled at 3- and 12-months after initial enrollment in the hospital. Interventions/exposures are denoted for this group for study procedures that are completed during an in-person post-hospital visit.
Interventions
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).
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)
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).
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).
An HME filter is a sponge that is placed in the tubing between a patient and breathing machine. It reduces the amount of heat and moisture a patient loses when on a breathing machine. Moisture from breath is collected in this filter. The filter is changed every few hours. When the filter is changed, it will be saved to collect the moisture that it contains and run tests on it. HME filters will be collected in hospital on intubated patients only (Cohorts A, B).
Patients on a breathing machine have a breathing tube in their trachea that connects their lungs to the breathing machine. A smaller tube, called a suction catheter, will be placed through the larger tube and fluid will be gently sucked out. Tracheal aspirate will be collected in hospital on intubated patients only (Cohorts A, B)
The NBBAL procedure involves putting a flexible rubber tube through the breathing tube into the airway of one of the lungs. A small amount of fluid is injected into the lung and then a gentle suction is used to collect fluid. Only patients who pass a safety screen showing that they are not at high risk for complications will have the NBBAL procedure performed. NBBAL will be performed in hospital on intubated patients only (Cohort A)
Participants will be contacted by email, text, and /or phone to give updates about their health. These surveys will ask questions about quality of life, mental health, return to work, and re-admission to the hospital. (Cohort A)
At visits 3 and 12 months following hospitalization (Long-term Outcomes Cohort) Chair Stand Test: For this test the participant will sit in a chair. They will then stand as quickly as possible without using their upper body to assist them. Balance Test: For this test the participant will stand unsupported for 10 seconds with their feet in 3 different positions. 4-meter walk: For this test the participant will walk 4 meters as quickly as possible.
At visits 3 and 12 months following hospitalization (Long-term Outcomes Cohort): The participant will squeeze a machine called a hand-held dynamometer 3 times with all their strength.
At visits 3 and 12 months following hospitalization (Cohort A - Long-term Outcomes Cohort): The participant will sit at a computer and follow the prompts on the screen. This test takes about 45 minutes.
At visits 3 and 12 months following hospitalization (Long-term Outcomes Cohort): The participant will undergo ultrasound on the quadriceps muscle on the dominant side of their body.
At visits 3 and 12 months following hospitalization (Long-term Outcomes Cohort): A dynamometer will be used to measure muscle strength in the dominant leg.
At a visit 12 months following hospitalization (Long-term Outcomes Cohort): The participant will have a clip placed on their nose and will be given a plastic mouthpiece that is connected to a machine called a spirometer. They will place their lips tightly around the mouthpiece and take in as big and deep of a breath as possible and then blow out as hard and fast as they can.
At a visit 12 months following hospitalization (Long-term Outcomes Cohort): The participant will have a clip on their nose. They will put their mouth over a mouthpiece that is attached to a machine. This machine will deliver a small amount of carbon dioxide when they breathe in and will also record the results of the test. They will then take a few normal breaths. Next they will inhale deeply and exhale completely. They will breathe in quickly through their mouth and hold their breath for 10 seconds or as long as they can. Then they will breathe out.
At a visit 12 months following hospitalization (Long-term Outcomes Cohort): The participant will undergo a Chest Computed Tomography (CT) scan which uses special X-ray equipment to take detailed pictures of the lungs.
Eligibility Criteria
This study enrolls hospitalized adult patients ≥18 years who have or are at high risk of developing ARDS, pneumonia, and/or sepsis.
You may qualify if:
- 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.
- 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.
- +1 more criteria
You may not qualify if:
- Patient/legally authorized representative (LAR) declines participation.
- 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).
- 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Fresno Community Hospital and Medical Center
Fresno, California, 93721, United States
Stanford University
Palo Alto, California, 94305, United States
San Francisco General Hospital
San Francisco, California, 94110, United States
University of California, San Francisco
San Francisco, California, 94143, United States
University of Colorado, Denver
Denver, Colorado, 80045, United States
Denver Health and Hospital Authority
Denver, Colorado, 80204, United States
National Jewish Health
Denver, Colorado, 80206, United States
UC Health Medical Center of the Rockies
Loveland, Colorado, 80538, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
University of Chicago
Chicago, Illinois, 60637, United States
Johns Hopkins Univeristy
Baltimore, Maryland, 21218, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Duke University
Durham, North Carolina, 27710, United States
University of Cincinnati
Cincinnati, Ohio, 45219, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Meharry Medical College
Nashville, Tennessee, 37208, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
University of Utah
Salt Lake City, Utah, 84132, United States
Related Publications (1)
Semler MW, Bernard GR, Aaron SD, Angus DC, Biros MH, Brower RG, Calfee CS, Colantuoni EA, Ferguson ND, Gong MN, Hopkins RO, Hough CL, Iwashyna TJ, Levy BD, Martin TR, Matthay MA, Mizgerd JP, Moss M, Needham DM, Self WH, Seymour CW, Stapleton RD, Thompson BT, Wunderink RG, Aggarwal NR, Reineck LA. Identifying Clinical Research Priorities in Adult Pulmonary and Critical Care. NHLBI Working Group Report. Am J Respir Crit Care Med. 2020 Aug 15;202(4):511-523. doi: 10.1164/rccm.201908-1595WS.
PMID: 32150460BACKGROUND
Related Links
Biospecimen
Biospecimens to be collected include blood; urine; stool; oral, nasal, and rectal swabs; heat moisture exchange (HME) filter fluid; tracheal aspirate; and non-bronchoscopic bronchoalveolar lavage.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wesley H. Self, MD, MPH
Vanderbilt University Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- APS Consortium Coordinating Center Principal Investigator
Study Record Dates
First Submitted
July 16, 2024
First Posted
July 26, 2024
Study Start
July 25, 2024
Primary Completion (Estimated)
April 30, 2029
Study Completion (Estimated)
April 30, 2029
Last Updated
February 20, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- The first large subset of APS data and biospecimens is anticipated to be available for distribution no earlier than the first quarter of calendar year 2026. The full cohort of data and biospecimens will be available in 2028.
- Access Criteria
- Requests for use of biospecimens and/or data will be reviewed by the APS Consortium Steering Committee through the end of the program. After the program has completed, requests will be reviewed by the US National Heart, Lung, and Blood Institute (NHLBI).
During conduct of the APS Consortium study procedures, data, biospecimens, and radiographic images will be collected by enrolling sites and transmitted to the APS Consortium Coordinating Center at Vanderbilt University Medical Center. Data and biospecimens will be organized and catalogued at the coordinating center. Additionally, the coordinating center will periodically transmit data and biospecimens to repositories managed by the National Heart, Lung, and Blood Institute (NHLBI) -- BioData Catalyst (data repository) and BioLINCC (biospecimen repository). During the period of performance for the APS Consortium, requests for data and/or biospecimens for use in ancillary studies will be reviewed for approval by the APS Steering Committee. After the completion of the APS Consortium period of performance, requests for data and/or biospecimens for use in ancillary studies will be governed by NHLBI through the BioData Catalyst and BioLINCC programs.