The Th9/IL-9 and Early Enteral Nutrition in Sepsis | NCT03791866

Studies
The Th9/IL-9 and Early Enteral Nutrition in Sepsis

NCT03791866

Sponsor

Nanjing First Hospital, Nanjing Medical University

Status

Unknown status

Last Update Posted

Jan 3, 2019Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Sepsis
Intestinal Mucosal Barrier
Th9 Cells
Enteral Nutrition

Interventions

Nutrition

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2018Actual

Primary Completion Date

Dec 31, 2019Estimated

Completion Date

Jun 30, 2020Estimated

First Submitted Date

Dec 21, 2018

First Submission Date that Met QC Criteria

Dec 31, 2018

First Posted Date

Jan 3, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 31, 2018

Last Update Posted Date

Jan 3, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

XiangWang, Director, Nanjing First Hospital, Nanjing Medical UniversityPrincipal Investigator

Lead Sponsor

Nanjing First Hospital, Nanjing Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
30% target total enteral nutrition	Experimental	Other: Nutrition
60% target total enteral nutrition	Experimental	Other: Nutrition
100% target total enteral nutrition	Active Comparator	Other: Nutrition

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nutrition	Other	Enteral nutrition	100% target total enteral nutrition 30% target total enteral nutrition 60% target total enteral nutrition

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
28-d mortality		28 days

Secondary Outcomes

Measure	Description	Time Frame
Serum Th9 lymphocyte percentages	Serum Th9 lymphocyte percentages	7 days
Concentration of serum IL-9	Concentration of serum IL-9

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jie Zhou	Contact	+8613913893984		565219791@qq.com

Overall Officials

Name	Affiliation	Role
Jia-Kui Sun	The First Affiliated Hospital with Nanjing Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nanjing First Hospital	Recruiting	Nanjing	Jiangsu	210000	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33941281	Derived	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.

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

ID	Term
D009747	Nutritional Physiological Phenomena
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D006304	Health Status