Enteral Feeding, Immune System Disorder, Sepsis
Conditions
Brief summary
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
Interventions
OTHERenteral nutrition
early enteral nutrition group or delayed enteral nutrition group
Sponsors
Nanjing First Hospital, Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 28-d mortality | 28 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| immune parameters | 7 days | serum Th17 and Treg lymphocyte percentages |
Countries
China
Outcome results
None listed