The Role of Circulating CircRNAs and MicroRNAs in Acute Lung Injury

Acute Respiratory Distress Syndrome Clinical Trial

— TRCCMALI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03766204
• Other study ID #: 20181204
• Status: Recruiting
• Start date: January 1, 2017
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2018
• Source: Changhai Hospital
• Contact: Zhao-fan Xia, MD;PHD
• Phone: 86-21-31161821
• Email: xiazhaofan[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Lung Injury
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Locations

Country	Name	City	State
China	Department of Burn and Trauma Sugery, Changhai Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Receiving Mechanical Ventilation		up to 28 days
Primary	Fraction of Inspired Oxygen (FiO2)/Partial Arterial Oxygen Pressure (PO2)		up to 28 days
Primary	Acute Physiology and Chronic Health Evaluation (APACHE) II Scores	APACHE II scores range from 0 to 71. A higher values represent a worse outcome	up to 28 days
Primary	plasma circRNAs		Day 3
Primary	plasma microRNAs		Day 3
Secondary	Length of Stay in the ICU		1 year
Secondary	Length of Hospital Stay		1 year
Secondary	Days of Unassisted Ventilation		1 year
Secondary	Death		up to 28