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

December 31, 2018 updated by: XiangWang, Nanjing First Hospital, Nanjing Medical University

The Roles of Th9/IL-9 in the Mechanisms of Early Enteral Nutrition Maintaining Intestinal Mucosal Barrier in Sepsis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Nanjing First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Clinical diagnosis of sepsis
  2. Within 3 days of sepsis onset before ICU admission
  3. No artificial nutrition (enteral or parenteral nutrition) were provided before ICU admission

Exclusion Criteria:

  1. Ileus
  2. Digestive tract hemorrhage
  3. Inflammatory bowel disease
  4. Abdominal hypertension (IAP >25mmHg)
  5. Cancer or chronic organ dysfunction (e.g., hepatic or renal dysfunction)
  6. Malnutrition or immunodeficiency
  7. Long-term use of hormones

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 30% target total enteral nutrition
Other: Nutrition
Enteral nutrition
Experimental: 60% target total enteral nutrition
Other: Nutrition
Enteral nutrition
Active Comparator: 100% target total enteral nutrition
Other: Nutrition
Enteral nutrition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
28-d mortality
Time Frame: 28 days
28 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing First Hospital, Nanjing Medical University

Investigators

  • Principal Investigator: Jia-Kui Sun, The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

June 30, 2020

Study Registration Dates

First Submitted

December 21, 2018

First Submitted That Met QC Criteria

December 31, 2018

First Posted (Actual)

January 3, 2019

Study Record Updates

Last Update Posted (Actual)

January 3, 2019

Last Update Submitted That Met QC Criteria

December 31, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YKK17102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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