The APS Phenotyping Study

Vanderbilt University Medical Center4,000 enrolled

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 APS phenotyping study will enroll hospitalized adult patients ≥18 years old who have or are at risk of developing ARDS, sepsis, or pneumonia. Participation in this study will involve collection of clinical data, completing questionnaires, and collection of samples such as blood, urine, and stool. Participants who are mechanically ventilated will also provide samples from their respiratory track. Data and samples will be collected both during and after hospitalization. Analyses to understand the mechanisms underlying ARDS, pneumonia, and sepsis will be conducted, with goals including the classification of patients with ARDS, pneumonia, and sepsis into biologically based phenotype categories and identifying new targets for future therapeutic trials.

Study Type

OBSERVATIONAL

Enrollment

4,000

Conditions

ARDS Sepsis Pneumonia

Interventions

Blood collectionOTHER

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 CollectionOTHER

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 swabsOTHER

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (20)

Fresno Community Hospital and Medical Center

Fresno, California, United States

Outcomes

Primary Outcomes

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.

Time frame: Through day 7

Secondary Outcomes

Death

All-cause mortality

Time frame: 28 days, 3 months, 12 months

Central Contacts

Wesley H. Self, MD, MPH

CONTACT

1-615-936-8047 wesley.self@vumc.org

Jillian P. Rhoads, PhD

CONTACT

1-615-936-3773 jillian.p.rhoads.1@vumc.org

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Stool collectionOTHER

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 collectionOTHER

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 collectionOTHER

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)

SurveysOTHER

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 batteryOTHER

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 strengthOTHER

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 SignsOTHER

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 UltrasoundOTHER

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 StrengthOTHER

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.

SpirometryOTHER

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 ScanRADIATION

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.

Stanford University

Palo Alto, California, United States

RECRUITING

San Francisco General Hospital

San Francisco, California, United States

RECRUITING

University of California, San Francisco

San Francisco, California, United States

RECRUITING

University of Colorado, Denver

Denver, Colorado, United States

RECRUITING

Denver Health and Hospital Authority

Denver, Colorado, United States

RECRUITING

National Jewish Health

Denver, Colorado, United States

RECRUITING

UC Health Medical Center of the Rockies

Loveland, Colorado, United States

RECRUITING

Northwestern Memorial Hospital

Chicago, Illinois, United States

RECRUITING

University of Chicago

Chicago, Illinois, United States

RECRUITING

...and 10 more locations