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NCT06521502Recruiting

The APS Phenotyping Study

Vanderbilt University Medical Center

Start Date

7/25/2024

Completion Date

4/30/2029

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.

Detailed Description

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

OTHER

Blood collection

OTHER

Urine Collection

OTHER

Nasal, oral, and rectal swabs

OTHER

Stool collection

OTHER

Heat Moisture Exchange Filter collection

OTHER

Tracheal Aspirate sample collection

PROCEDURE

Non-bronchoscopic bronchoalveolar lavage (NBBAL)

OTHER

Surveys

OTHER

Short physical performance battery

OTHER

Hand grip strength

OTHER

CNS Vital Signs

OTHER

Muscle Ultrasound

OTHER

Muscle Strength

OTHER

Spirometry

OTHER

Lung Diffusion Testing (DLCO)

RADIATION

Chest CT Scan

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Conditions

ARDSSepsisPneumonia

Locations

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