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临床试验/NCT03766204
NCT03766204招募中不适用

Relationship Between Circulating CircRNAs and MicroRNAs and Severity of Experimental and Clinical ALI/ARDS

Changhai Hospital1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
250
试验地点
1
主要终点
Acute Physiology and Chronic Health Evaluation (APACHE) II Scores

研究概览

简要总结

Efforts to identify circulating factors that predict severity of acute lung injury/acute respiratory distress syndrome(ALI/ARDS)patients is unrevealing. The primary purpose of this study is to verify circRNAs and microRNAs might be potential novel ALI/ARDS biomarkers and could play roles in pathogenesis of ALI/ARDS.

详细描述

Acute lung injury (ALI) or acute respiratory distress syndrome (ARDS) is a devastating cause of morbidity and mortality characterized by alveolar epithelial and endothelial injury. Despite recent advances in pathogenetic mechanisms and therapy strategies of ALI, efforts to identify circulating factors that predict severity of ALI/ARDS patients have been unrevealing.

Circular RNAs (circRNAs) are a novel class of endogenous non-coding RNA with a covalently continuous closed-loop structure. Compared with traditional linear RNAs, circRNAs are more stable and resistant to RNase R due to the absence of 5' caps and 3' tails, which show clear advantages in acting as novel molecular biomarkers for many diseases. In addition, many studies have reported that circRNAs can bind to microRNAs (miRNAs), acting as "miRNA sponges" which are named competitive endogenous RNAs (ceRNAs), and can regulate gene expression at the transcriptional or post-transcriptional level. Evidence indicates that circRNAs play important roles in cancers and other diseases such as tuberculosis and intervertebral disc degeneration. As no published research has studied the expression and role of circRNAs in the pathology and pathogenesis of ALI/ARDS, the investigators aimed to validate the aberrant expression of circRNAs in ALI/ARDS and explore the potential pathological mechanism in which circRNAs are involved.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of ALI/ARDS
  • Informed consent was obtained from either the subjects themselves or from designated surrogates before enrollment in the study.

排除标准

  • Patients who have chronic lung disease before enrollment.
  • Patients who have severe organ dysfunction, autoimmune diseases and tumor.
  • Women who are pregnant or breast-feeding.
  • Patients who, in the opinion of the Investigator, have any other medical condition which renders the patient unable to complete the study or which would interfere with optimal participation in the study or produce significant risk to the patient.
  • Patients participating in or planning to enroll in another clinical trial during the time of the study.

结局指标

主要结局

Acute Physiology and Chronic Health Evaluation (APACHE) II Scores

时间窗: up to 28 days

APACHE II scores range from 0 to 71. A higher values represent a worse outcome

plasma microRNAs

时间窗: Day 3

Number of Participants Receiving Mechanical Ventilation

时间窗: up to 28 days

plasma circRNAs

时间窗: Day 3

Fraction of Inspired Oxygen (FiO2)/Partial Arterial Oxygen Pressure (PO2)

时间窗: up to 28 days

次要结局

  • Length of Stay in the ICU(1 year)
  • Length of Hospital Stay(1 year)
  • Days of Unassisted Ventilation(1 year)
  • Death(up to 28)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhaofan Xia

President

Changhai Hospital

研究点 (1)

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