The Th9/IL-9 and Early Enteral Nutrition in Sepsis

Nanjing First Hospital, Nanjing Medical University60 enrolled

Overview

The investigators aim to evaluate the roles of Th9/IL-9 in the mechanisms of early enteral nutrition (EEN) maintaining intestinal mucosal barrier in 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. In addition, the investigators also aim to evaluate the effects of different proportions of target total enteral nutrition on the prognosis of sepsis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Sepsis Intestinal Mucosal Barrier Th9 Cells Enteral Nutrition

Interventions

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

Outcomes

Primary Outcomes

28-d mortality

Time frame: 28 days

Secondary Outcomes

Serum Th9 lymphocyte percentages

Time frame: 7 days

Concentration of serum IL-9

Time frame: 7 days

Concentration of serum iFABP

Time frame: 7 days

Concentration of serum DAO

Time frame: 7 days

The Th9/IL-9 and Early Enteral Nutrition in Sepsis

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts