The APS Phenotyping Study

Официальное название

The ARDS, Pneumonia, and Sepsis (APS) Consortium: A Prospective Observational Study to Evaluate Phenotypes

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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).
• Другое 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)
• Другое 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).
• Другое 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).
• Другое 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).
• Другое 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)
• Процедура 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)
• Другое 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)
• Другое 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.
• Другое 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.

Первичные конечные точки

• ARDS, pneumonia, and sepsis classification [Срок оценки: Through day 7]

Вторичные конечные точки (1)

• Death [Срок оценки: 28 days, 3 months, 12 months]

Критерии участия

Критерии включения

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):

• Age ≥ 18 years old
• 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.")
• 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.
• 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:

• Hemophagocytic lymphohistiocytosis.
• Suspected acute rheumatologic or auto-immune disease with pulmonary or cardiovascular manifestations.
• Suspected cryptogenic organizing pneumonia presenting acutely.
• Suspected diffuse alveolar hemorrhage.
• Suspected acute anaphylaxis.
• Suspected acute pulmonary drug toxicity.

Критерии исключения

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):

• Patient/legally authorized representative (LAR) declines participation.
• Acute cardiovascular or pulmonary organ dysfunction (inclusion criterion #3) has been present for > 48 hours.
• Patient has been in an eligible unit (inclusion criterion #2) for more than 120 hours (five days).
• Patient is no longer expected to meet the acute cardiovascular or pulmonary organ dysfunction inclusion criterion (inclusion criterion #3) 24 hours after enrollment.
• Patient desires comfort measures only.
• Patient is a prisoner.
• Patient had out-of-hospital cardiac arrest leading to this hospitalization.
• Residence immediately before this hospitalization in a long-term acute care facility.
• Presence of tracheostomy for respiratory failure.
• Home invasive mechanical ventilation or non-invasive ventilation (except patients with non-invasive ventilation prescribed as a treatment for a sleep disorder may participate).
• 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.
• Inability or unwillingness to complete study-specified blood draws, for example, due to local policies about hemoglobin thresholds for research blood draws.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 20 центров

• Fresno Community Hospital and Medical Center — Fresno
• Stanford University — Palo Alto
• San Francisco General Hospital — San Francisco
• University of California, San Francisco — San Francisco
• University of Colorado, Denver — Denver
• Denver Health and Hospital Authority — Denver
• National Jewish Health — Denver
• UC Health Medical Center of the Rockies — Loveland
• … и ещё 12 центров

Публикации

• Semler MW, Bernard GR, Aaron SD, Angus DC, Biros MH, Brower RG, Calfee CS, Colantuoni EA, Ferguson ND, Gong MN, Hopkins RO, Hough CL, Iwashyna TJ, Levy BD, Martin TR, Matthay MA, Mizgerd JP, Moss M, Needham DM, Self WH, Seymour CW, Stapleton RD, Thompson BT, Wunderink RG, Aggarwal NR, Reineck LA. Identifying Clinical Research Priorities in Adult Pulmonary and Critical Care. NHLBI Working Group Rep PMID 32150460
• Self WH, Calfee CS, Brown SM, Moss M, Ware LB, Hyzy RC, Meyer NJ, Reilly JP, Harhay MO, Shashaty MGS, Sandsmark DK, Auriemma CL, Jones TK, Prescott HC, Dickson RP, Nelson K, McSparron JI, Lagina M, Denstaedt SJ, Admon AJ, Patel BK, Wolfe KS, Hite RD, Hudock KM, Bastarache JA, Koyama T, Kerchberger VE, Ely EW, Jackson JC, Sinha P, Mudd PA, Kraft BD, Fremont RD, Singh R, Aggarwal NR, Jolley SE, Burn PMID 42442528

Идентификаторы

NCT: NCT06521502 · 240088

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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