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

N

Nanjing Medical University

Status

Unknown

Conditions

Enteral Nutrition
Intestinal Mucosal Barrier
Th9 Cells
Sepsis

Treatments

Other: Nutrition

Study type

Interventional

Funder types

Other

Identifiers

NCT03791866
YKK17102

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 3 patient groups

30% target total enteral nutrition
Experimental group
Treatment:
Other: Nutrition
60% target total enteral nutrition
Experimental group
Treatment:
Other: Nutrition
100% target total enteral nutrition
Active Comparator group
Treatment:
Other: Nutrition

Trial contacts and locations

1

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Central trial contact

Jie Zhou

Data sourced from clinicaltrials.gov

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