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The APS Phenotyping Study
Sponsor: Vanderbilt University Medical Center
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.
Official title: The ARDS, Pneumonia, and Sepsis (APS) Consortium: A Prospective Observational Study to Evaluate Phenotypes
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
4000
Start Date
2024-07-25
Completion Date
2029-04-30
Last Updated
2026-02-20
Healthy Volunteers
No
Interventions
Blood collection
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 Collection
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
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 collection
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).
Heat Moisture Exchange Filter collection
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).
Tracheal Aspirate sample collection
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)
Non-bronchoscopic bronchoalveolar lavage (NBBAL)
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)
Surveys
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)
Short physical performance battery
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.
Hand grip strength
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.
CNS Vital Signs
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.
Muscle Ultrasound
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.
Muscle Strength
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.
Spirometry
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.
Lung Diffusion Testing (DLCO)
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.
Chest CT Scan
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.
Locations (20)
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
UC Health Medical Center of the Rockies
Loveland, Colorado, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Johns Hopkins Univeristy
Baltimore, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Duke University
Durham, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Meharry Medical College
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Intermountain Medical Center
Murray, Utah, United States
University of Utah
Salt Lake City, Utah, United States