跳至主要内容
临床试验/NCT03844893
NCT03844893Unknown不适用

Macrophage Programing in Acute Lung Injury

National Jewish Health0 个研究点目标入组 56 人开始时间: 2019年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
56
主要终点
Evaluation and roles of macrophages during ARDS

研究概览

简要总结

The histologic hallmarks of lung inflammation and in the extreme, acute respiratory distress syndrome (ARDS), include intense accumulation of inflammatory cells in the airspaces and interstitium, injury to alveolar epithelial and endothelial cells, loss of epithelial-capillary integrity and accumulation of edema fluid in the interstitium and airspaces. Accordingly, for alveolar repair to occur inflammation must be halted, debris and inflammatory cells removed, injured tissue cells replaced, and capillary barrier function re-established. Macrophages are key players in all of these. Here the investigators hypothesize that resident alveolar macrophages and recruited macrophages serve completely different functions, acting independently (i.e. division of labor) yet cooperatively (synergism).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Written, informed consent (by surrogate if unconscious or if altered mental status)
  • Admission to a Medical Intensive care unit
  • Orally/nasally intubated, evaluable within 24 h of intubation or onset of ARDS
  • Expected to remain mechanically ventilated for at least 48 h after the first study procedure.

排除标准

  • Treatment with immunosuppressants in the prior 3 months (antineoplastic agents, tumor necrosis factor alpha antagonists, cyclosporine, methotrexate, azathioprine, or mycophenolate. Treatment with glucocorticoids for septic shock is acceptable).
  • History of solid organ or bone marrow transplantation
  • History of chronic lung disease (e.g. COPD, pulmonary fibrosis, cystic fibrosis)
  • Human immunodeficiency virus positivity
  • Severe or massive hemoptysis
  • At significant risk for bleeding (INR > 3 or PTT > 3x normal)
  • Presence of an advanced directive to withhold life-sustaining treatment
  • Morbid state or expected to survive less than 14 days because of an advanced co-morbid medical condition;

结局指标

主要结局

Evaluation and roles of macrophages during ARDS

时间窗: 10 days

Evaluation of recruited alveolar macrophages will be isolated using FACS and subjected to RNA sequencing. Pro-inflammatory and pro-reparative modules will be assessed in the data set expression of transcription factors reported to drive macrophage polarization (HIF-1α, NF-kB, STAT-1, STAT-3, STAT-6, PPARγ, PU.1) will be assessed.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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