Back to resultsThe Th9/IL-9 and Early Enteral Nutrition in Sepsis
Primary Purpose
Sepsis, Intestinal Mucosal Barrier, Th9 Cells
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
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 HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
30% target total enteral nutrition
60% target total enteral nutrition
100% target total enteral nutrition
Arm Description
Outcomes
Primary Outcome Measures
28-d mortality
Secondary Outcome Measures
Serum Th9 lymphocyte percentages
Serum Th9 lymphocyte percentages
Concentration of serum IL-9
Concentration of serum IL-9
Concentration of serum iFABP
Concentration of serum iFABP
Concentration of serum DAO
Concentration of serum DAO
Full Information
NCT ID
NCT03791866
First Posted
December 21, 2018
Last Updated
December 31, 2018
Sponsor
Nanjing First Hospital, Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03791866
Brief Title
The Th9/IL-9 and Early Enteral Nutrition in Sepsis
Official Title
The Roles of Th9/IL-9 in the Mechanisms of Early Enteral Nutrition Maintaining Intestinal Mucosal Barrier in Sepsis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Intestinal Mucosal Barrier, Th9 Cells, Enteral Nutrition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
30% target total enteral nutrition
Arm Type
Experimental
Arm Title
60% target total enteral nutrition
Arm Type
Experimental
Arm Title
100% target total enteral nutrition
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Nutrition
Intervention Description
Enteral nutrition
Primary Outcome Measure Information:
Title
28-d mortality
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Serum Th9 lymphocyte percentages
Description
Serum Th9 lymphocyte percentages
Time Frame
7 days
Title
Concentration of serum IL-9
Description
Concentration of serum IL-9
Time Frame
7 days
Title
Concentration of serum iFABP
Description
Concentration of serum iFABP
Time Frame
7 days
Title
Concentration of serum DAO
Description
Concentration of serum DAO
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jie Zhou
Phone
+8613913893984
Email
565219791@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jia-Kui Sun
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Zhou
Phone
+8613913893984
Email
565219791@qq.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
33941281
Citation
Sun JK, Zhou J, Sun XP, Shen X, Zhu DM, Wang X, Zhou SM, Mu XW. Interleukin-9 promotes intestinal barrier injury of sepsis: a translational research. J Intensive Care. 2021 May 3;9(1):37. doi: 10.1186/s40560-021-00550-y.
Results Reference
derived
Learn more about this trial
The Th9/IL-9 and Early Enteral Nutrition in Sepsis
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