Sepsis Complicated With ARDSNCT05476029
Changes of Exosomes and Biomarkers in Plasma and Alveolar Lavage Fluid of Patients With Sepsis Complicated With ARDS
An observational study of Sepsis Complicated With ARDS, run by Tianjin Nankai Hospital at 1 site in China.
Trial summary
In this study, serum samples and alveolar lavage fluid from patients with sepsis complicated with ARDS were studied. The differential miRNAs of inflammatory exosomes in patients with sepsis lung injury were screened, and Sestrin2, HO-1 and PPARγ proteins, oxidative stress and inflammatory indexes in serum and alveolar… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis Complicated With ARDS
- What is being tested?
- Blood samples and alveolar lavage fluid were collected
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 25 Jul 2022to 30 Dec 2023
- How long will I take part?
- 1 Year
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with sepsis meeting the criteria of sepsis -3 and complicating lung injury
Who may be able to join
- Age≥18 years old；
- Patients with sepsis who meet the criteria for sepsis -3；
- Agree to participate in this study and sign informed consent；
Who cannot join
- Refuse to participate in this study；
- Patients with left atrial hypertension to prevent the inclusion of patients with abnormal oxygenation index due to cardiogenic pulmonary edema；
- Pregnant or lactation patients
- Patients are currently being enrolled in another study
- The attending physician or researcher considers that there are other circumstances (reasons to be noted) that are not suitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Plasma and alveolar lavage fluid
Tianjin, Tianjin Municipality, 300100
Lirong Gong, MD, 300100, soundglr@163.com
About this study
Official title: Study on Exosomes and Biomarkers in Plasma and Alveolar Lavage Fluid of Patients With Sepsis Complicated With ARDS
In this study, serum samples and alveolar lavage fluid from patients with sepsis complicated with ARDS were studied. The differential miRNAs of inflammatory exosomes in patients with sepsis lung injury were screened, and Sestrin2, HO-1 and PPARγ proteins, oxidative stress and inflammatory indexes in serum and alveolar lavage fluid were measured simultaneously, to explore the relationship between HO-1, oxidative inflammatory indexes and metabolic indexes. These results provide an important reference for assisting the management of ARDS disease and predicting the adverse outcomes of sepsis patients with ARDS.
Read the detailed description
- Title: Study on exosomes and biomarkers in plasma and alveolar lavage fluid of patients with sepsis complicated with ARDS
- Research center: monocentric
- The Design of the study: Randomized, double-blind
- The population of the study: 1)Age ≥18, no gender or ethnic limitation. 2) Patients with sepsis who meet the criteria of sepsis -3 and ARDS is defined according to Berlin standard.
- Interventions: Within 24h after admission to ICU, blood samples and alveolar lavage fluid were collected and transferred to a cleaning tube and stored in a refrigerator at -80°C for exosome sorting and identification, differential miRNAs, and analysis of serum oxidation and inflammatory indicators.
- The aim of the research: to explore the relationship between HO-1, oxidative inflammatory indexes and metabolic indexes and provide an important reference for assisting the management of ARDS disease and predicting the adverse outcomes of sepsis patients with ARDS.
- Outcome： Differential miRNAs of inflammatory exosomes were screened from patients with septic lung injury, and ho-1, PPARγ or other positive indicators were used to regulate differential miRNAs 9. The estimated duration of the study：2 years.
- Conditions
- Sepsis Complicated With ARDS
- Being tested
- Blood samples and alveolar lavage fluid were collected
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples and alveolar lavage fluid were collectedDiagnostic test
Blood samples and alveolar lavage fluid were collected for exosome sorting and identification, differential miRNAs, and analysis of serum oxidation and inflammatory indicators.
| Study group | Role | What they receive |
|---|---|---|
| Sepsis complicated with ARDS group | Blood samples and alveolar lavage fluid were collected within 24h after admission to ICU. After blood samples were collected, they were placed in static stratification at 4°C and centrifuged at 3000×g for 10 min. Serum samples and alveolar lavage fluid samples were transferred to a cleaning tube and stored in a refrigerator at -80°C for exosome sorting, identification, differential miRNAs, and analysis of serum oxidation and inflammatory indicators. Receives: Diagnostic Test: Blood samples and alveolar lavage fluid were collected | |
| control group | Blood samples and alveolar lavage fluid were collected. After blood samples were collected, they were placed in static stratification at 4°C and centrifuged at 3000×g for 10 min. Serum samples and alveolar lavage fluid samples were transferred to a cleaning tube and stored in a refrigerator at -80°C for exosome sorting, identification, differential miRNAs, and analysis of serum oxidation and inflammatory indicators. Receives: Diagnostic Test: Blood samples and alveolar lavage fluid were collected |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differential miRNAs of inflammatory exosomes were screened from patients with septic lung injury
Differential miRNAs of inflammatory exosomes were screened from patients with septic lung injury, and ho-1, PPARγ or other positive indicators were used to regulate differential miRNAs.
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start25 Jul 2022
- Primary completion30 May 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Sepsis Complicated With ARDSStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Tianjin Nankai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianbo Yu, Tianjin Nankai Hospital
- Investigators
- Jianbo Yu, MD,PhD, Study chair, Tianjin Nankai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05476029
- Sponsor's protocol ID
- NKYY_YXKT_IRB_2022_018_01
- Status last verified
- Jul 2022
- First submitted
- 24 Jul 2022
- Last updated
- 27 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang D, Wang X, Si M, Yang J, Sun S, Wu H, Cui S, Qu X, Yu X. Exosome-encapsulated miRNAs contribute to CXCL12/CXCR4-induced liver metastasis of colorectal cancer by enhancing M2 polarization of macrophages. Cancer Lett. 2020 Apr 1;474:36-52. doi: 10.1016/j.canlet.2020.01.005. Epub 2020 Jan 10.
PubMed 31931030Rezaei R, Baghaei K, Amani D, Piccin A, Hashemi SM, Asadzadeh Aghdaei H, Zali MR. Exosome-mediated delivery of functionally active miRNA-375-3p mimic regulate epithelial mesenchymal transition (EMT) of colon cancer cells. Life Sci. 2021 Mar 15;269:119035. doi: 10.1016/j.lfs.2021.119035. Epub 2021 Jan 13.
PubMed 33450254Kalluri R, LeBleu VS. The biology, function, and biomedical applications of exosomes. Science. 2020 Feb 7;367(6478):eaau6977. doi: 10.1126/science.aau6977.
PubMed 32029601Chekanova JA, Gregory BD, Reverdatto SV, Chen H, Kumar R, Hooker T, Yazaki J, Li P, Skiba N, Peng Q, Alonso J, Brukhin V, Grossniklaus U, Ecker JR, Belostotsky DA. Genome-wide high-resolution mapping of exosome substrates reveals hidden features in the Arabidopsis transcriptome. Cell. 2007 Dec 28;131(7):1340-53. doi: 10.1016/j.cell.2007.10.056.
PubMed 18160042Wu X, Liu Z, Hu L, Gu W, Zhu L. Exosomes derived from endothelial progenitor cells ameliorate acute lung injury by transferring miR-126. Exp Cell Res. 2018 Sep 1;370(1):13-23. doi: 10.1016/j.yexcr.2018.06.003. Epub 2018 Jun 5.
PubMed 29883714Zhou Y, Li P, Goodwin AJ, Cook JA, Halushka PV, Chang E, Zingarelli B, Fan H. Exosomes from endothelial progenitor cells improve outcomes of the lipopolysaccharide-induced acute lung injury. Crit Care. 2019 Feb 13;23(1):44. doi: 10.1186/s13054-019-2339-3.
PubMed 30760290Shin CH, Byun J, Lee K, Kim B, Noh YK, Tran NL, Park K, Kim SH, Kim TH, Oh SJ. Exosomal miRNA-19a and miRNA-614 Induced by Air Pollutants Promote Proinflammatory M1 Macrophage Polarization via Regulation of RORalpha Expression in Human Respiratory Mucosal Microenvironment. J Immunol. 2020 Dec 1;205(11):3179-3190. doi: 10.4049/jimmunol.2000456. Epub 2020 Oct 28.
PubMed 33115854Zheng L, Su J, Zhang Z, Jiang L, Wei J, Xu X, Lv S. Salidroside regulates inflammatory pathway of alveolar macrophages by influencing the secretion of miRNA-146a exosomes by lung epithelial cells. Sci Rep. 2020 Nov 27;10(1):20750. doi: 10.1038/s41598-020-77448-6.
PubMed 33247202
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Exosomes and Biomarkers in Plasma and Alveolar Lavage Fluid of Patients With Sepsis Complicated With ARDS
- ClinicalTrials.gov ID
- NCT05476029
- Acronym / sponsor ID
- NKYY_YXKT_IRB_2022_018_01
- Conditions
- Sepsis Complicated With ARDS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tianjin Nankai HospitalUniversity, hospital or other
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 27 Jul 2022 (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.
In this study, serum samples and alveolar lavage fluid from patients with sepsis complicated with ARDS were studied. The differential miRNAs of inflammatory exosomes in patients with sepsis lung injury were screened, and Sestrin2, HO-1 and PPARγ proteins, oxidative stress and inflammatory indexes in serum and alveolar lavage fluid were measured simultaneously, to explore the relationship between HO-1, oxidative inflammatory indexes and metabolic indexes. These results provide an important reference for assisting the management of ARDS disease and predicting the adverse outcomes of sepsis patients with ARDS.
Detailed description
- Title: Study on exosomes and biomarkers in plasma and alveolar lavage fluid of patients with sepsis complicated with ARDS
- Research center: monocentric
- The Design of the study: Randomized, double-blind
- The population of the study: 1)Age ≥18, no gender or ethnic limitation. 2) Patients with sepsis who meet the criteria of sepsis -3 and ARDS is defined according to Berlin standard.
- Interventions: Within 24h after admission to ICU, blood samples and alveolar lavage fluid were collected and transferred to a cleaning tube and stored in a refrigerator at -80°C for exosome sorting and identification, differential miRNAs, and analysis of serum oxidation and inflammatory indicators.
- The aim of the research: to explore the relationship between HO-1, oxidative inflammatory indexes and metabolic indexes and provide an important reference for assisting the management of ARDS disease and predicting the adverse outcomes of sepsis patients with ARDS.
- Outcome： Differential miRNAs of inflammatory exosomes were screened from patients with septic lung injury, and ho-1, PPARγ or other positive indicators were used to regulate differential miRNAs 9. The estimated duration of the study：2 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sepsis complicated with ARDS group | – | Diagnostic Test: Blood samples and alveolar lavage fluid were collectedBlood samples and alveolar lavage fluid were collected within 24h after admission to ICU. After blood samples were collected, they were placed in static stratification at 4°C and centrifuged at 3000×g for 10 min. Serum samples and alveolar lavage fluid samples were transferred to a cleaning tube and stored in a refrigerator at -80°C for exosome sorting, identification, differential miRNAs, and analysis of serum oxidation and inflammatory indicators. |
| control group | – | Diagnostic Test: Blood samples and alveolar lavage fluid were collectedBlood samples and alveolar lavage fluid were collected. After blood samples were collected, they were placed in static stratification at 4°C and centrifuged at 3000×g for 10 min. Serum samples and alveolar lavage fluid samples were transferred to a cleaning tube and stored in a refrigerator at -80°C for exosome sorting, identification, differential miRNAs, and analysis of serum oxidation and inflammatory indicators. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with sepsis meeting the criteria of sepsis -3 and complicating lung injury
Key inclusion criteria (3 listed)
- Age≥18 years old；
- Patients with sepsis who meet the criteria for sepsis -3；
- Agree to participate in this study and sign informed consent；
Key exclusion criteria (5 listed)
- Refuse to participate in this study；
- Patients with left atrial hypertension to prevent the inclusion of patients with abnormal oxygenation index due to cardiogenic pulmonary edema；
- Pregnant or lactation patients
- Patients are currently being enrolled in another study
- The attending physician or researcher considers that there are other circumstances (reasons to be noted) that are not suitable for participation in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samples and alveolar lavage fluid were collectedBlood samples and alveolar lavage fluid were collected for exosome sorting and identification, differential miRNAs, and analysis of serum oxidation and inflammatory indicators. | Diagnostic test | Sepsis complicated with ARDS group, control group |
Primary outcome
Differential miRNAs of inflammatory exosomes were screened from patients with septic lung injury
Time frame: 1year
Differential miRNAs of inflammatory exosomes were screened from patients with septic lung injury, and ho-1, PPARγ or other positive indicators were used to regulate differential miRNAs.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Results publication: PubMed 31931030Wang D, Wang X, Si M, Yang J, Sun S, Wu H, Cui S, Qu X, Yu X. Exosome-encapsulated miRNAs contribute to CXCL12/CXCR4-induced liver metastasis of colorectal cancer by enhancing M2 polarization of macrophages. Cancer Lett. 2020 Apr 1;474:36-52. doi: 10.1016/j.canlet.2020.01.005. Epub 2020 Jan 10.
- Results publication: PubMed 33450254Rezaei R, Baghaei K, Amani D, Piccin A, Hashemi SM, Asadzadeh Aghdaei H, Zali MR. Exosome-mediated delivery of functionally active miRNA-375-3p mimic regulate epithelial mesenchymal transition (EMT) of colon cancer cells. Life Sci. 2021 Mar 15;269:119035. doi: 10.1016/j.lfs.2021.119035. Epub 2021 Jan 13.
- Results publication: PubMed 32029601Kalluri R, LeBleu VS. The biology, function, and biomedical applications of exosomes. Science. 2020 Feb 7;367(6478):eaau6977. doi: 10.1126/science.aau6977.
- Results publication: PubMed 18160042Chekanova JA, Gregory BD, Reverdatto SV, Chen H, Kumar R, Hooker T, Yazaki J, Li P, Skiba N, Peng Q, Alonso J, Brukhin V, Grossniklaus U, Ecker JR, Belostotsky DA. Genome-wide high-resolution mapping of exosome substrates reveals hidden features in the Arabidopsis transcriptome. Cell. 2007 Dec 28;131(7):1340-53. doi: 10.1016/j.cell.2007.10.056.
- Results publication: PubMed 29883714Wu X, Liu Z, Hu L, Gu W, Zhu L. Exosomes derived from endothelial progenitor cells ameliorate acute lung injury by transferring miR-126. Exp Cell Res. 2018 Sep 1;370(1):13-23. doi: 10.1016/j.yexcr.2018.06.003. Epub 2018 Jun 5.
- Results publication: PubMed 30760290Zhou Y, Li P, Goodwin AJ, Cook JA, Halushka PV, Chang E, Zingarelli B, Fan H. Exosomes from endothelial progenitor cells improve outcomes of the lipopolysaccharide-induced acute lung injury. Crit Care. 2019 Feb 13;23(1):44. doi: 10.1186/s13054-019-2339-3.
- Results publication: PubMed 33115854Shin CH, Byun J, Lee K, Kim B, Noh YK, Tran NL, Park K, Kim SH, Kim TH, Oh SJ. Exosomal miRNA-19a and miRNA-614 Induced by Air Pollutants Promote Proinflammatory M1 Macrophage Polarization via Regulation of RORalpha Expression in Human Respiratory Mucosal Microenvironment. J Immunol. 2020 Dec 1;205(11):3179-3190. doi: 10.4049/jimmunol.2000456. Epub 2020 Oct 28.
- Results publication: PubMed 33247202Zheng L, Su J, Zhang Z, Jiang L, Wei J, Xu X, Lv S. Salidroside regulates inflammatory pathway of alveolar macrophages by influencing the secretion of miRNA-146a exosomes by lung epithelial cells. Sci Rep. 2020 Nov 27;10(1):20750. doi: 10.1038/s41598-020-77448-6.
- Individual participant dataSharing planned: No
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.
Jianbo Yu, MD,PhD study chair
Tianjin Nankai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis Complicated With ARDS, run by Tianjin Nankai Hospital at 1 site in 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 3 inclusion and 5 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 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Lirong Gong, MD (15332039197, soundglr@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differential miRNAs of inflammatory exosomes were screened from patients with septic lung injury (time frame: 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05476029, which also lists 8 linked publications.
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 27 Jul 2022.