The Roles of IL-9/E-cadherin and Ferroptosis in Intestinal Mucosal Barrier Injury in Sepsis

NCT05410665 | Unknown

• 1 other identifier: YKK21134
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to evaluate the roles of IL-9/E-cadheirin and ferroptosis in the intestinal mucosal barrier injury of sepsis. The results of this study would lay the foundation for revealing the mechanisms of EEN improving immune imbalance of sepsis and provide a new idea to the early treatment of sepsis.

Conditions

Sepsis; Intestinal Mucosal Barrier; Ferroptosis

Outcome Measures

Primary Outcomes (1)

• Incidence of intestinal barrier injury incidence of intestinal barrier injury

  intestinal barrier injury

  7 days

Secondary Outcomes (1)

• Incidence of ferroptosis

  7 days

Study Arms (2)

Sepsis group

Adult septic patients admitted into the intensive care unit (ICU) of Nanjing First Hospital. The diagnostic criteria for sepsis were in accordance with the surviving sepsis guidelines.

Procedure: Standard treatments for sepsis

Control group

Baseline data (including age, sex, body-mass index, disease severity scores) matched adult non-septic critical patients in our ICU.

Interventions

Standard treatments for sepsis PROCEDURE

Standard treatments for others

Sepsis group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Septic patients and baseline data (including age, sex, body-mass index, disease severity scores) matched adult non-septic critical patients in ICU.

You may qualify if:

• Clinical diagnosis of sepsis
• Within 3 days of sepsis onset before ICU admission
• No artificial nutrition (enteral or parenteral nutrition) were provided before ICU admission

You may not qualify if:

• Ileus
• Digestive tract hemorrhage
• Inflammatory bowel disease
• Cancer or chronic organ dysfunction (e.g., hepatic or renal dysfunction)
• Malnutrition or immunodeficiency
• Long-term use of hormones

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jia-Kui Sun, Dr.

  Nanjing First Hospital, Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Zhou, Dr.

CONTACT

+8613913893984; 565219791@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2022
• First Posted: June 8, 2022
• Study Start: May 31, 2022
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: June 8, 2022

Record last verified: 2022-06

Locations

CN (1)