ARDS, HumanNCT05061212
The Mechanism of Extracellular Vesicles Containing Mitochondrial DNA in ARDS Lung Injury Caused by Extrapulmonary Sepsis
An observational study of ARDS, Human, run by Southeast University, China.
Trial summary
The acute respiratory distress syndrome (ARDS) remains a common and morbid complication of critical illness. Sepsis contribute to a lot of ARDS cases, but mechanisms by which non-pulmonary insults such as extrapulmonary sepsis propagate lung injury remain unclear. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS, Human
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We enrolled patients with ARDS caused by abdominal infection
Who may be able to join
- Patients with ARDS caused by abdominal infection
Who cannot join
- age <18 years old or pregnancy; death or discharge within 24 hours after admission; advanced tumor
About this study
The acute respiratory distress syndrome (ARDS) remains a common and morbid complication of critical illness. Sepsis contribute to a lot of ARDS cases, but mechanisms by which non-pulmonary insults such as extrapulmonary sepsis propagate lung injury remain unclear. Most eukaryotic cells release small anuclear membrane-bound vesicles into the extracellular environment in either physiological or pathophysiological conditions, often called extracellular vesicles (EVs) .Through their cargo containing bioactive molecules such as proteins, mRNAs, and microRNAs and their interaction with target cells, EVs are recognized as important mediators of cellular communication. Mitochondrial contents are clearly present in EVs, and mitochondrial cargo within EVs have been shown to stimulate the production of proinflammatory cytokines, further enhancing LPS-induced inflammation. Among the mitochondrial contents, mtDNA was present at higher levels in EVs.Therefore, we hypothesis, EVs containing mtDNA play an important role in the occurrence and development of ARDS caused by extrapulmonary sepsis.
Read the 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.
- Conditions
- ARDS, Human
- Medical subject headings
- Respiratory Distress Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
Measured: All patients were followed up for 28 days
Secondary outcomes (2)
Ventilator days
Measured: All patients were followed up for 28 days
ICU stay
Measured: All patients were followed up for 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start1 Oct 2021 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS, HumanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun Pan, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05061212
- Sponsor's protocol ID
- ARDS-mtDNA EVs
- Status last verified
- Sep 2021
- First submitted
- 18 Sep 2021
- Last updated
- 29 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mechanism of Extracellular Vesicles Containing Mitochondrial DNA in ARDS Lung Injury Caused by Extrapulmonary Sepsis
- ClinicalTrials.gov ID
- NCT05061212
- Acronym / sponsor ID
- ARDS-mtDNA EVs
- Conditions
- ARDS, Human
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 29 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The acute respiratory distress syndrome (ARDS) remains a common and morbid complication of critical illness. Sepsis contribute to a lot of ARDS cases, but mechanisms by which non-pulmonary insults such as extrapulmonary sepsis propagate lung injury remain unclear. Most eukaryotic cells release small anuclear membrane-bound vesicles into the extracellular environment in either physiological or pathophysiological conditions, often called extracellular vesicles (EVs) .Through their cargo containing bioactive molecules such as proteins, mRNAs, and microRNAs and their interaction with target cells, EVs are recognized as important mediators of cellular communication. Mitochondrial contents are clearly present in EVs, and mitochondrial cargo within EVs have been shown to stimulate the production of proinflammatory cytokines, further enhancing LPS-induced inflammation. Among the mitochondrial contents, mtDNA was present at higher levels in EVs.Therefore, we hypothesis, EVs containing mtDNA play an important role in the occurrence and development of ARDS caused by extrapulmonary sepsis.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We enrolled patients with ARDS caused by abdominal infection
Key inclusion criteria (1 listed)
- Patients with ARDS caused by abdominal infection
Key exclusion criteria (1 listed)
- age <18 years old or pregnancy; death or discharge within 24 hours after admission; advanced tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
28-day mortality
Time frame: All patients were followed up for 28 days
2 secondary outcomes
Ventilator days
Time frame: All patients were followed up for 28 days
ICU stay
Time frame: All patients were followed up for 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS, Human, run by Southeast University, China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day mortality (time frame: All patients were followed up for 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.