NCT03385850

Brief Summary

The investigators aim to evaluate the roles of Th17/Treg cells and IL-23/IL-17 axis in the mechanisms of early enteral nutrition (EEN) correcting immune imbalance of sepsis by means of improving the intestinal flora disturbance. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable sepsis

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

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, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 29, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

March 5, 2019

Status Verified

March 1, 2019

Enrollment Period

9 months

First QC Date

December 14, 2017

Last Update Submit

March 2, 2019

Conditions

SepsisImmune System DisorderEnteral Feeding

Outcome Measures

Primary Outcomes (1)

  • 28-d mortality

    28 days

Secondary Outcomes (2)

  • immune parameters

    7 days

  • immune parameters

    7 days

Study Arms (2)

early enteral nutrition

EXPERIMENTAL
Other: enteral nutrition

delayed enteral nutrition

ACTIVE COMPARATOR
Other: enteral nutrition

Interventions

enteral nutritionOTHER

early enteral nutrition group or delayed enteral nutrition group

delayed enteral nutritionearly enteral nutrition

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

SepsisImmune System Diseases

Interventions

Enteral Nutrition

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Officials

  • Xiang Wang

    The First Affiliated Hospital with Nanjing Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

December 14, 2017

First Posted

December 29, 2017

Study Start

October 1, 2017

Primary Completion

June 30, 2018

Study Completion

December 31, 2018

Last Updated

March 5, 2019

Record last verified: 2019-03

Locations

CN(1)