The ARDS, Pneumonia, and Sepsis (APS) Consortium: A Prospective Observational Study to Evaluate Phenotypes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 4,000
- 试验地点
- 33
- 主要终点
- ARDS, pneumonia, and sepsis classification
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Urine Collection (Other)
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.
干预措施: Blood collection (Other)
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.
干预措施: Nasal, oral, and rectal swabs (Other)
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.
干预措施: Stool collection (Other)
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.
干预措施: Heat Moisture Exchange Filter collection (Other)
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.
干预措施: Tracheal Aspirate sample collection (Other)
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.
干预措施: Non-bronchoscopic bronchoalveolar lavage (NBBAL) (Procedure)
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.
干预措施: Surveys (Other)
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.
干预措施: Blood collection (Other)
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.
干预措施: Urine Collection (Other)
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.
干预措施: Nasal, oral, and rectal swabs (Other)
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.
干预措施: Stool collection (Other)
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.
干预措施: Heat Moisture Exchange Filter collection (Other)
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.
干预措施: Tracheal Aspirate sample collection (Other)
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.
干预措施: Blood collection (Other)
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.
干预措施: Nasal, oral, and rectal swabs (Other)
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.
干预措施: Stool collection (Other)
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.
干预措施: Short physical performance battery (Other)
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.
干预措施: Hand grip strength (Other)
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.
干预措施: CNS Vital Signs (Other)
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.
干预措施: Muscle Ultrasound (Other)
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.
干预措施: Muscle Strength (Other)
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.
干预措施: Spirometry (Other)
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.
干预措施: Lung Diffusion Testing (DLCO) (Other)
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.
干预措施: Chest CT Scan (Radiation)
结局指标
主要结局
ARDS, pneumonia, and sepsis classification
时间窗: Through day 7
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.
次要结局
- Death(28 days, 3 months, 12 months)
研究者
Wesley Self
APS Consortium Coordinating Center Principal Investigator
Vanderbilt University Medical Center