The Roles of IL-9/E-cadherin and Ferroptosis in Intestina... | NCT05410665

Studies
The Roles of IL-9/E-cadherin and Ferroptosis in Intestinal Mucosal Barrier Injury in Sepsis

NCT05410665

Sponsor

Nanjing First Hospital, Nanjing Medical University

Status

Unknown status

Last Update Posted

Jun 8, 2022Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Sepsis
Intestinal Mucosal Barrier
Ferroptosis

Interventions

Standard treatments for sepsis

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

Jun 2022

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

May 31, 2022Actual

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Jun 30, 2024Estimated

First Submitted Date

Jun 5, 2022

First Submission Date that Met QC Criteria

Jun 5, 2022

First Posted Date

Jun 8, 2022Actual

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

Jun 5, 2022

Last Update Posted Date

Jun 8, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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 IL-9/E-cadheirin and ferroptosis in the intestinal mucosal barrier injury of 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sepsis group		Adult septic patients admitted into the intensive care unit (ICU) of Nanjing First Hospital. The diagnostic criteria for sepsis were in accordance with the surviving sepsis guidelines.	Procedure: Standard treatments for sepsis
Control group		Baseline data (including age, sex, body-mass index, disease severity scores) matched adult non-septic critical patients in our ICU.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Standard treatments for sepsis	Procedure	Standard treatments for others	Sepsis group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of intestinal barrier injury incidence of intestinal barrier injury	intestinal barrier injury	7 days

Secondary Outcomes

Measure	Description	Time Frame
Incidence of ferroptosis	ferroptosis	7 days

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
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

80 Years

Standard Ages

AdultOlder Adult

Study Population

Septic patients and baseline data (including age, sex, body-mass index, disease severity scores) matched adult non-septic critical patients in ICU.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

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

Overall Officials

Name	Affiliation	Role
Jia-Kui Sun, Dr.	Nanjing First Hospital, Nanjing Medical University	Principal Investigator

Locations

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

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided