The Th17/Treg Cells and IL-23/IL-17 Axis and Early Enteral Nutrition in Sepsis

Nanjing First Hospital, Nanjing Medical University53 enrolled

Overview

The investigators aim to evaluate the roles of Th17/Treg cells and IL-23/IL-17 axis in the mechanisms of early enteral nutrition (EEN) correcting immune imbalance of sepsis by means of improving the intestinal flora disturbance. 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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Sepsis Immune System Disorder Enteral Feeding

Interventions

enteral nutritionOTHER

early enteral nutrition group or delayed enteral nutrition group

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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. Abdominal hypertension (IAP \>25mmHg) 5. Cancer or chronic organ dysfunction (e.g., hepatic or renal dysfunction) 6. Malnutrition or immunodeficiency 7. Long-term use of hormones

Locations (1)

Nanjing First Hospital

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

28-d mortality

Time frame: 28 days

Secondary Outcomes

immune parameters

serum Th17 and Treg lymphocyte percentages

Time frame: 7 days

immune parameters

IL-23, IL-17, IL-6, IL-10 levels

Time frame: 7 days

Data from ClinicalTrials.gov

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