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

Nanjing Medical University

Status: Unknown

Conditions: Enteral Nutrition; Intestinal Mucosal Barrier; Th9 Cells; Sepsis

Treatments: Other: Nutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT03791866

YKK17102

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

30% target total enteral nutrition

Experimental group

Treatment:

Other: Nutrition

60% target total enteral nutrition

Experimental group

Treatment:

Other: Nutrition

100% target total enteral nutrition

Active Comparator group

Treatment:

Other: Nutrition