The Effect and Mechanism of lncRNA NBR2 Regulating Endothelial Pyroptosis by Targeting GSDMD in Sepsis

NCT ID: NCT04427371

Last Updated: 2020-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-22

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Sepsis is a life-threatening disease characterized by multi-organ failure due to dysregulated host response to infection, with high global mortality of 30-50%. One of the most important pathophysiologic hallmarks in sepsis is vascular endothelial injury that contributes to the severity and outcome of the syndrome. Effective treatments for endothelial cell injury in sepsis have been lacking to improve prognosis. Endothelial pyroptosis is a vital mechanism of vascular endothelial injury in sepsis; mitigation or abolishment of endothelial cell pyroptosis alleviate vascular endothelial damage and improve the prognosis of sepsis mice. Gasdermin D (GSDMD) mediated endothelial pyroptosis plays a critical role in modulating vascular endothelial injury in sepsis.

Long non-coding RNA (lncRNA), as a class of non-coding protein RNA longer than 200 kD, contributes to a variety of cell biological processes. The dysregulation of lncRNA results in the occurrence and development of tumors, diabetes, sepsis and other diseases. Therefore, we detected lncRNA and mRNA expression profile in 26 blood samples of septic patients using Arraystar LncRNA Microarray. We found lncRNA NBR2 regulates septic endothelial pyroptosis.

To assess any correlation of pyroptosis levels with relevant endothelial cell injury parameters and determine the prognostic value in septic patients. we measured the levels of pyroptosis in patients admitted to the Department of Critical Care Medicine for sepsis and investigated the correlation with related markers of endothelium injury. Furthermore, we determined the prognostic value of pyroptosis levels for the mortality of patients with sepsis.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

We measured the levels of pyroptosis in patients admitted to the Department of Critical Care Medicine for sepsis and investigated the correlation with related markers of endothelium injury. Furthermore, we determined the prognostic value of pyroptosis levels for the mortality of patients with sepsis.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sepsis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

survivors

Improve or under treatment

the levels of pyroptosis

Intervention Type OTHER

Blood samples were taken to detect plasma lncRNA NBR2 levels and GSDMD protein level.

nonsurvivors

all-cause 28-day mortality

the levels of pyroptosis

Intervention Type OTHER

Blood samples were taken to detect plasma lncRNA NBR2 levels and GSDMD protein level.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

the levels of pyroptosis

Blood samples were taken to detect plasma lncRNA NBR2 levels and GSDMD protein level.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Suspected or confirmed infection
* The sequential organ failure score (SOFA score) increases by more than or equal to 2 points on the basis
* Sign the informed consent

Exclusion Criteria

1. the age \< 18 or \> 80 years of age
2. pregnant
3. tumor
4. viral hepatitis or liver cirrhosis
5. chronic renal tubular nephritis, chronic renal insufficiency
6. ulcerative colitis or crohn's disease
7. active systemic lupus erythematosus (SLE)
8. acute myocardial infarction
9. acute pancreatitis
10. engaged in other clinical subjects
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Jianfeng Xie

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jianfeng Xie

Dr.

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Zhongda Hospital, School of Medicine, Southeast University

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Fei Peng, Dr

Role: CONTACT

025-83262553

Yi Yang, Prof.

Role: CONTACT

025-83262553

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Fei Peng, Dr

Role: primary

025-83262553

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SoutheastUChina

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.