The APS Phenotyping Study
NCT Number: NCT06521502
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: ARDS|Sepsis|Pneumonia
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
Sponsor: Vanderbilt University Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 4000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-25
Completion Date: 2028-04-30
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|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|Henry Ford Health System, Detroit, Michigan, 48202, United States|Washington University School of Medicine, Saint 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

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.

Primary Outcome Measures: 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 Outcome Measures: Death, All-cause mortality, 28 days, 3 months, 6 months, 12 months
Other Outcome Measures: Invasive ventilator free days, Days alive and free of invasive mechanical ventilation through day 28, In-hospital through day 28|Ventilatory support free days, Days alive and free of invasive mechanical ventilation (IMV), non-invasive ventilation (NIV), and high flow nasal cannula (HFNC) through day 28, In-hospital through day 28|Vasopressor free days, Days alive and free of vasopressor use through day 28, In-hospital through day 28|New kidney replacement therapy free days, Days alive and free of new kidney replacement free days through day 28, In-hospital through day 28|Organ support free days, Days alive and free of IMV, NIV, HFNC, vasopressors, and new kidney replacement therapy, In-hospital through day 28|Coma and delirium free days, Days alive and free of coma and delirium (defined by confusion assessment method (CAM)-ICU and Richmond Agitation Sedation Scale (RASS score) through day 7, In hospital through day 7|Oxygen free days, Days alive and free of new supplemental oxygen therapy through day 28, In hospital through day 28|Hospital free days, Days alive and out of the hospital through day 28, In hospital through day 28|ICU free days, Days alive and out of the ICU through day 28, In hospital through day 28|Acute kidney injury (AKI), AKI defined by creatinine criteria from Kidney Disease Improving Global Outcomes (KDIGO), In hospital through day 28|Major adverse kidney events (MAKE), Death, new kidney replacement therapy, or persistent doubling of serum creatinine, In-hospital through day 28|Extracorporeal membrane oxygenation (ECMO), New receipt of ECMO therapy, In-hospital through day 28|Sequential Organ Failure Assessment (SOFA) score, Organ dysfunction scoring system that assesses the performance of 6 organ systems (respiratory, cardiovascular, hepatic, renal, coagulation, and neurological). Score range is 0 to 24. A higher score indicates greater (worse) organ dysfunction., Through day 7|Central Nervous System (CNS) vital signs score, CNS vital signs is a computer-based neurocognitive assessment that evaluates memory, psychomotor speed, reaction time, complex attention and cognitive flexibility. The summary score is called the Neurocognitive Index. Scoring produces a relative score for the individual relative to the American normative sample controlled for age; mean score is 100; the standard deviation is 15; higher scores represent better neurocognitive function., 3, 6, 12 months|Short Physical Performance Battery Protocol, Physical performance assessment, 3, 6, 12 months|Handgrip strength, Physical strength assessment, 3, 6, 12 months|Quadriceps muscle ultrasound, Physical muscle fitness assessment, 3, 6, 12 months|Pulmonary spirometry, including forced vital capacity (FVC), and forced expiratory volume in 1 second (FEV1)., FVC is the volume of air that can be forcibly exhaled after full inspiration, measured in liters. FEV1 is the volume of air that can be forcibly exhaled in 1 second after full inspiration, measured in liters., 12 months|Diffusing capacity for carbon monoxide (DLCO), Lung function assessment, 12 months|EuroQol-5 Dimension-5 Level (EQ-5D-5L) quality of life assessment, A tool to measure health related quality of life. A score of 1 indicates the best possible health state and a score \<0 is the worst possible health state., 3, 6, 12 months|Impact of Event Scale (IES)-6, PTSD assessment scored out of 4, with a score of ≥ 1.75 denoting likely PTSD, 3, 6, 12 months|Hospital Anxiety and Depression Scale (HADS), A fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score \>8 denotes anxiety or depression., 3, 6, 12 months|Modified Medical Research Council (mMRC) dyspnea score, The mMRC scale is a self-assessment tool used to measure the level of impairment caused by breathlessness during daily activities, rated on a scale from 0 (no breathlessness) to 4 (severe limitation)., 3, 6, 12 months|Clinical frailty scale, A nine-point scale based on clinical evaluation of mobility, energy, physical activity, and function. Higher scores indicate increased frailty., 3, 6, 12 months|World Health Organization Disability Assessment Schedule (WHODAS) 2.0, A tool that measures how a health condition affects a person's ability to function in everyday life. Scored from 0-100 where 0 indicates no disability and 100 indicates full disability., 3, 6, 12 months|Return to work, Assessment of returning to work after critical illness, 3, 6, 12 months|Financial toxicity, Assessment of financial stress after critical illness, 3, 6, 12 months|Housing instability, Assessment of housing after critical illness, 3, 6, 12 months