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

• Sponsor: Jianfeng Xie (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04427371
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 43.3
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Sepsis	Other: the levels of pyroptosis

Detailed Description

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Zhongda Hospital, School of Medicine, Southeast University
• Actual Study Start Date: May 22, 2020
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
survivors Improve or under treatment	Other: the levels of pyroptosis; Blood samples were taken to detect plasma lncRNA NBR2 levels and GSDMD protein level.
nonsurvivors all-cause 28-day mortality	Other: the levels of pyroptosis; Blood samples were taken to detect plasma lncRNA NBR2 levels and GSDMD protein level.

Outcome Measures

Primary Outcome Measures

1. 28-day mortality [28-day]

   all-cause 28-day mortality

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhongda Hospital, School of Medicine, Southeast University	Nanjing	Jiangsu	China	210009

Sponsors and Collaborators

• Jianfeng Xie

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jianfeng Xie, Dr., Southeast University, China
• ClinicalTrials.gov Identifier: NCT04427371
• Other Study ID Numbers: SoutheastUChina
• First Posted: Jun 11, 2020
• Last Update Posted: Jun 11, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jianfeng Xie, Dr., Southeast University, China: endothelial cell injury; pyroptosis; lncRNA NBR2; gasdermin D
• Additional relevant MeSH terms: Sepsis

Study Results

No Results Posted as of Jun 11, 2020