The Role of Circulating CircRNAs and MicroRNAs in Acute Lung Injury
TRCCMALI
Relationship Between Circulating CircRNAs and MicroRNAs and Severity of Experimental and Clinical ALI/ARDS
1 other identifier
observational
250
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
December 4, 2018
CompletedFirst Posted
Study publicly available on registry
December 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedDecember 6, 2018
December 1, 2018
7 years
December 4, 2018
December 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Number of Participants Receiving Mechanical Ventilation
up to 28 days
Fraction of Inspired Oxygen (FiO2)/Partial Arterial Oxygen Pressure (PO2)
up to 28 days
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
plasma circRNAs
Day 3
plasma microRNAs
Day 3
Secondary Outcomes (4)
Length of Stay in the ICU
1 year
Length of Hospital Stay
1 year
Days of Unassisted Ventilation
1 year
Death
up to 28
Study Arms (2)
ARDS patients
137 patients were enrolled consecutively over a two-year time period (2017-2018) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 18 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
Healthy volunteers
Forty healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
Eligibility Criteria
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.
You may qualify if:
- Clinical diagnosis of ALI/ARDS
- Informed consent was obtained from either the subjects themselves or from designated surrogates before enrollment in the study.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Burn and Trauma Sugery, Changhai Hospital
Shanghai, Shanghai Municipality, 200433, China
Biospecimen
ARDS patients and healthy volunteers
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Zhao-fan Xia, MD;PHD
Department of Burn Sugery, Changhai Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- President
Study Record Dates
First Submitted
December 4, 2018
First Posted
December 6, 2018
Study Start
January 1, 2017
Primary Completion
December 31, 2023
Study Completion
December 31, 2024
Last Updated
December 6, 2018
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will not share