The Th9/IL-9 and Early Enteral Nutrition in Sepsis
The Roles of Th9/IL-9 in the Mechanisms of Early Enteral Nutrition Maintaining Intestinal Mucosal Barrier in Sepsis
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable sepsis
Started Oct 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2018
CompletedFirst Submitted
Initial submission to the registry
December 21, 2018
CompletedFirst Posted
Study publicly available on registry
January 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedJanuary 3, 2019
December 1, 2018
1.2 years
December 21, 2018
December 31, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
28-d mortality
28 days
Secondary Outcomes (4)
Serum Th9 lymphocyte percentages
7 days
Concentration of serum IL-9
7 days
Concentration of serum iFABP
7 days
Concentration of serum DAO
7 days
Study Arms (3)
30% target total enteral nutrition
EXPERIMENTAL60% target total enteral nutrition
EXPERIMENTAL100% target total enteral nutrition
ACTIVE COMPARATORInterventions
Enteral nutrition
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nanjing First Hospital
Nanjing, Jiangsu, 210000, China
Related Publications (1)
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.
PMID: 33941281DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jia-Kui Sun
The First Affiliated Hospital with Nanjing Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
December 21, 2018
First Posted
January 3, 2019
Study Start
October 1, 2018
Primary Completion
December 31, 2019
Study Completion
June 30, 2020
Last Updated
January 3, 2019
Record last verified: 2018-12