NCT05061212

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2021

Status
unknown

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

First Submitted

Initial submission to the registry

September 18, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 29, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

11 months

First QC Date

September 18, 2021

Last Update Submit

September 18, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 28-day mortality

    All patients were followed up for 28 days

Secondary Outcomes (2)

  • Ventilator days

    All patients were followed up for 28 days

  • ICU stay

    All patients were followed up for 28 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

We enrolled patients with ARDS caused by abdominal infection

You may qualify if:

  • Patients with ARDS caused by abdominal infection

You may not qualify if:

  • age \<18 years old or pregnancy; death or discharge within 24 hours after admission; advanced tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University

Study Record Dates

First Submitted

September 18, 2021

First Posted

September 29, 2021

Study Start

October 1, 2021

Primary Completion

September 1, 2022

Study Completion

December 31, 2022

Last Updated

September 29, 2021

Record last verified: 2021-09