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

Not Applicable

Completed

• Conditions: Sepsis; Enteral Feeding; Immune System Disorder
• Interventions: Other: enteral nutrition

• Registration Number: NCT03385850
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-01
• Study First Submitted: 2017-12-14
• Study First Submitted QC: 2017-12-27
• Study First Posted: 2017-12-29
• Primary Completion: 2018-06-30
• Study Completion: 2018-12-31
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-02
• Last Update Posted: 2019-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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
delayed enteral nutrition	enteral nutrition	-
early enteral nutrition	enteral nutrition	-

Primary Outcome Measures

Name	Time	Method
28-d mortality	28 days

Secondary Outcome Measures

Name	Time	Method
immune parameters	7 days	IL-23, IL-17, IL-6, IL-10 levels

Trial Locations

Locations (1)

Nanjing First Hospital; 🇨🇳 Nanjing, Jiangsu, China