Clinical trial NCT03766204: The Role of Circulating CircRNAs and MicroRNAs in Acute Lung Injury
Official title: Relationship Between Circulating CircRNAs and MicroRNAs and Severity of Experimental and Clinical ALI/ARDS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Lung Injury
Acute Respiratory Distress Syndrome
Keywords: circRNAs
microRNAs
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2018-12-06
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with and without ARDS were screened from Changhai Hospital. Patients were enrolled consecutively over a 2-year time period (2017-2018). All enrolled patients with ALI met the American-European Consensus Committee criteria.In addition, healthy individuals were recruited from the general population.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of Participants Receiving Mechanical Ventilation
timeFrame: up to 28 days
measure: Fraction of Inspired Oxygen (FiO2)/Partial Arterial Oxygen Pressure (PO2)
timeFrame: up to 28 days
measure: Acute Physiology and Chronic Health Evaluation (APACHE) II Scores
timeFrame: up to 28 days
measure: plasma circRNAs
timeFrame: Day 3
measure: plasma microRNAs
timeFrame: Day 3
Secondary outcomes:
measure: Length of Stay in the ICU
timeFrame: 1 year
measure: Length of Hospital Stay
timeFrame: 1 year
measure: Days of Unassisted Ventilation
timeFrame: 1 year
measure: Death
timeFrame: up to 28
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Burn and Trauma Sugery, Changhai Hospital
state: Shanghai
Study officials:
affiliation: Department of Burn Sugery, Changhai Hospital
name: Zhao-fan Xia, MD;PHD
role: STUDY_DIRECTOR
References: