- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05061212
The Mechanism of Extracellular Vesicles Containing Mitochondrial DNA in ARDS Lung Injury Caused by Extrapulmonary Sepsis
Study Overview
Status
Conditions
Detailed Description
Inclusion criteria: Patients with ARDS caused by abdominal infection Exclusion criteria: age <18 years old or pregnancy; death or discharge within 24 hours after admission; advanced tumor The pathological information of the patients was collected on 24h, 48h after admission including demographic data, Acute Physiology and Chronic Health Evaluation (APACHE) II score , number of organ failures included in the Sequential Organ Failure Assessment (SOFA) score. The levels of lactate and inflammatory mediators (i.e., plasma C-reactive protein and procalcitonin) were detected on 24h and 48h after admission. All patients were followed up for 28 days, and all-cause mortality was recorded. The durations of mechanical ventilation and ICU stay were also recorded. The primary outcome was mortality on Day 28. Secondary outcomes included the ventilator days and ICU length of stay.
Peripheral blood samples (2 mL) were collected on 24h and 48h after admission to the ICU. EVs were isolated from the plasma, and mtDNA concentration of plasma DNA was evaluated by RT-qPCR.
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Patients with ARDS caused by abdominal infection
Exclusion Criteria:
age <18 years old or pregnancy; death or discharge within 24 hours after admission; advanced tumor
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
28-day mortality
Time Frame: All patients were followed up for 28 days
|
All patients were followed up for 28 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Ventilator days
Time Frame: All patients were followed up for 28 days
|
All patients were followed up for 28 days
|
ICU stay
Time Frame: All patients were followed up for 28 days
|
All patients were followed up for 28 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ARDS-mtDNA EVs
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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