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

Not Applicable

• Conditions: Sepsis; Intestinal Mucosal Barrier; Enteral Nutrition; Th9 Cells
• Interventions: Other: Nutrition

• Registration Number: NCT03791866
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-01
• Status Verified: 2018-12
• Study First Submitted: 2018-12-21
• Study First Submitted QC: 2018-12-31
• Last Update Submitted: 2018-12-31
• Study First Posted: 2019-01-03
• Last Update Posted: 2019-01-03
• Primary Completion: 2019-12-31
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
30% target total enteral nutrition	Nutrition	-
60% target total enteral nutrition	Nutrition	-
100% target total enteral nutrition	Nutrition	-

Primary Outcome Measures

Name	Time	Method
28-d mortality	28 days

Secondary Outcome Measures

Name	Time	Method
Serum Th9 lymphocyte percentages	7 days	Serum Th9 lymphocyte percentages
Concentration of serum IL-9	7 days	Concentration of serum IL-9
Concentration of serum iFABP	7 days	Concentration of serum iFABP
Concentration of serum DAO	7 days	Concentration of serum DAO

Trial Locations

Locations (1)

Nanjing First Hospital; 🇨🇳 Nanjing, Jiangsu, China