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

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.

Study Overview

• Status: Recruiting
• Conditions: Sepsis; Intestinal Mucosal Barrier; Ferroptosis
• Intervention / Treatment: Procedure: Standard treatments for sepsis

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Jie Zhou, Dr.; Phone Number: +8613913893984; Email: 565219791@qq.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Recruiting
      • Nanjing First Hospital
      • Contact: Jie Zhou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Standard treatments for others
Control group; Baseline data (including age, sex, body-mass index, disease severity scores) matched adult non-septic critical patients in our ICU.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of intestinal barrier injury incidence of intestinal barrier injury	intestinal barrier injury	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of ferroptosis	ferroptosis	7 days

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University
• Investigators: Principal Investigator: Jia-Kui Sun, Dr., Nanjing First Hospital, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 31, 2022
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): June 30, 2024

Study Registration Dates

• First Submitted: June 5, 2022
• First Submitted That Met QC Criteria: June 5, 2022
• First Posted (ACTUAL): June 8, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 8, 2022
• Last Update Submitted That Met QC Criteria: June 5, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: YKK21134

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No