DDX17 Orchestrate Septic Vascular Endothelial Pyroptosis by Controlling Gasdermin D Pore Formation

Sepsis Clinical Trial

Official title:

DDX17 Orchestrate Septic Vascular Endothelial Pyroptosis by Controlling Gasdermin D Pore Formation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06013033
• Other study ID #: 82202393
• Status: Not yet recruiting
• Start date: September 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2023
• Source: Zhongda Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Objective: To investigate the correlation between plasma levels of DDX17 and GSDMD with vascular endothelial dysfunction and prognosis of in sepsis patients.

Design: A single center, prospective, observational research. Participants: Patients with sepsis who are hospitalized to Southeast University Affiliated Zhongda Hospital and meet the diagnostic criteria for sepsis 3.0.

Inclusion criteria:1. There is a potential or clear infection; 2. Sequential organ failure score (SOFA score) increases by more than or equal to 2 points compared to the baseline value; 3. Sign informed consent form.

Exclusion criteria: Age<18 years old or>80 years old, pregnant women, tumor patients, including diseases that may be complicated with vascular endothelial damage: hypertension, acute and chronic hepatitis (hepatitis caused by virus), liver cirrhosis, PT prolongation after liver transplantation, acute myocardial infarction, chronic tubular nephritis, chronic renal insufficiency/maintenance hemodialysis, renal transplantation, interstitial pneumonia, acute pancreatitis, active phase of systemic lupus erythematosus Ulcerative colitis, Crohn's disease, HELLP syndrome.

Primary outcome: 28-day mortality. Secondary outcome: Plasma levels of DDX17 and GSDMD, and their correlation with vascular endothelial injury, severity, and prognosis in sepsis patients.

Description:

Data collection:Recording the population information, including name, sex, BMI, and past history. Recording disease-related information's, including diagnosis, infection site, pathogens, organ dysfunction, SOFA and APACHE II scores. Recording treatment measures of patients, including whether to use vasopressor, invasive mechanical ventilation, and continuous renal replacement therapy. Recording laboratory examination results, including leukocyte count, PCT and hs-CRP on D1, D3 and D7, respectively. All patients were followed up to 28 days. Patients were distributed to survival group and non-survival group according to the 28-day survival.

Sample collection: 3 mL of the patient's peripheral blood were drawn on Day1, 3, and 7, and the plasma was centrifuged and kept at -80 °C. ELISA content detection of DDX17 and GSDMD.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• There is a potential or clear infection;

• Sequential organ failure score (SOFA score) increases by more than or equal to 2 points compared to the baseline value;

• Sign informed consent form.

Exclusion Criteria:

• Age<18 years old or>80 years old

• pregnant women

• tumor patients

• including diseases that may be complicated with vascular endothelial damage:

hypertension, acute and chronic hepatitis (hepatitis caused by virus), liver cirrhosis, PT prolongation after liver transplantation, acute myocardial infarction, chronic tubular nephritis, chronic renal insufficiency/maintenance hemodialysis, renal transplantation, interstitial pneumonia, acute pancreatitis, active phase of systemic lupus erythematosus Ulcerative colitis, Crohn's disease, HELLP syndrome.

Related Conditions & MeSH terms

• Sepsis
• Septic Shock
• Shock, Septic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhongda Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day mortality		28 days
Secondary	correlation between plasma level of DDX17 and vascular endothelial injury, severity, and prognosis in sepsis patients		28 days
Secondary	correlation between plasma level of GSDMD and vascular endothelial injury, severity, and prognosis in sepsis patients		28 days