The APS Phenotyping Study

Conditions

• ARDS
• Pneumonia
• Sepsis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Blood collection — OTHER
  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 — OTHER
  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 — OTHER
  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 — OTHER
  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 — OTHER
  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 — OTHER
  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) — PROCEDURE
  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 — OTHER
  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 — OTHER
  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 — OTHER
  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 — OTHER
  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 — OTHER
  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 — OTHER
  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 — OTHER
  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) — OTHER
  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 — RADIATION
  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.

Study Details

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.

Key Dates

Start date

Jul 25, 2024

Status verified

Feb 2026

Primary completion

Apr 30, 2029

Completion

Apr 30, 2029

Study Design

Enrollment

4,000 participants (estimated)

Arms

• Arm: 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.
• Arm: 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.
• Arm: 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.

Primary Outcome Measure

ARDS, pneumonia, and sepsis classification [ Time Frame: Through day 7 ]

Central Contacts

• Wesley H. Self, MD, MPH
  1-615-936-8047
  [email protected]
• Jillian P. Rhoads, PhD
  1-615-936-3773
  [email protected]

Locations (20)

Find similar trials in Fresno, CA

Related Studies

• Natural History, Management, and Genetics of the Hyperimmunoglobulin E Recurrent Infection Syndrome (HIES)
  Recruiting · National Institute of Allergy and Infectious Diseases (NIAID) · Bethesda, Maryland
• Study of Lung Proteins in Patients With Pneumonia
  Recruiting · National Institutes of Health Clinical Center (CC) · Bethesda, Maryland
• Clinical Microbial Species & Antibiotic Resistance ID in ED Patients Presenting With Infection - is Rapid ID Possible & Accurate?
  Recruiting · Michigan State University · Lansing, Michigan
• STUDY00015328: Sepsis Endotypes
  Enrolling By Invitation · Milton S. Hershey Medical Center · Hershey, Pennsylvania