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

NCT ID: NCT03385850

Last Updated: 2019-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2018-12-31

Brief Summary

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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

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Conditions

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Sepsis Immune System Disorder Enteral Feeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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early enteral nutrition

Group Type EXPERIMENTAL

enteral nutrition

Intervention Type OTHER

early enteral nutrition group or delayed enteral nutrition group

delayed enteral nutrition

Group Type ACTIVE_COMPARATOR

enteral nutrition

Intervention Type OTHER

early enteral nutrition group or delayed enteral nutrition group

Interventions

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enteral nutrition

early enteral nutrition group or delayed enteral nutrition group

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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XiangWang

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiang Wang

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Locations

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Nanjing First Hospital

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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NanjingFirst

Identifier Type: -

Identifier Source: org_study_id

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