Back to resultsThe Th17/Treg Cells and IL-23/IL-17 Axis and Early Enteral Nutrition in Sepsis
Primary Purpose
Sepsis, Immune System Disorder, Enteral Feeding
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
enteral nutrition
Sponsored by
About this trial
This is an interventional treatment trial for Sepsis
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of sepsis
- Within 3 days of sepsis onset before ICU admission
- No artificial nutrition (enteral or parenteral nutrition) were provided before ICU admission
Exclusion Criteria:
- Ileus
- Digestive tract hemorrhage
- Inflammatory bowel disease
- Abdominal hypertension (IAP >25mmHg)
- Cancer or chronic organ dysfunction (e.g., hepatic or renal dysfunction)
- Malnutrition or immunodeficiency
- Long-term use of hormones
Sites / Locations
- Nanjing First Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
early enteral nutrition
delayed enteral nutrition
Arm Description
Outcomes
Primary Outcome Measures
28-d mortality
Secondary Outcome Measures
immune parameters
serum Th17 and Treg lymphocyte percentages
immune parameters
IL-23, IL-17, IL-6, IL-10 levels
Full Information
NCT ID
NCT03385850
First Posted
December 14, 2017
Last Updated
March 2, 2019
Sponsor
Nanjing First Hospital, Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03385850
Brief Title
The Th17/Treg Cells and IL-23/IL-17 Axis and Early Enteral Nutrition in Sepsis
Official Title
The Roles of Th17/Treg Cells and IL-23/IL-17 Axis in the Mechanisms of Early Enteral Nutrition Improving Immune Function of Sepsis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Immune System Disorder, Enteral Feeding
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
early enteral nutrition
Arm Type
Experimental
Arm Title
delayed enteral nutrition
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
enteral nutrition
Intervention Description
early enteral nutrition group or delayed enteral nutrition group
Primary Outcome Measure Information:
Title
28-d mortality
Time Frame
28 days
Secondary Outcome Measure Information:
Title
immune parameters
Description
serum Th17 and Treg lymphocyte percentages
Time Frame
7 days
Title
immune parameters
Description
IL-23, IL-17, IL-6, IL-10 levels
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of sepsis
Within 3 days of sepsis onset before ICU admission
No artificial nutrition (enteral or parenteral nutrition) were provided before ICU admission
Exclusion Criteria:
Ileus
Digestive tract hemorrhage
Inflammatory bowel disease
Abdominal hypertension (IAP >25mmHg)
Cancer or chronic organ dysfunction (e.g., hepatic or renal dysfunction)
Malnutrition or immunodeficiency
Long-term use of hormones
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiang Wang
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
There is a plan to make individual participant data (IPD) available to other researchers.
Learn more about this trial
The Th17/Treg Cells and IL-23/IL-17 Axis and Early Enteral Nutrition in Sepsis
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