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

• Sponsor: Nanjing First Hospital, Nanjing Medical University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03791866
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 21
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sepsis; Intestinal Mucosal Barrier; Th9 Cells; Enteral Nutrition	Other: Nutrition	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: The Roles of Th9/IL-9 in the Mechanisms of Early Enteral Nutrition Maintaining Intestinal Mucosal Barrier in Sepsis
• Actual Study Start Date: Oct 1, 2018
• Anticipated Primary Completion Date: Dec 31, 2019
• Anticipated Study Completion Date: Jun 30, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 28-d mortality [28 days]

Secondary Outcome Measures

1. Serum Th9 lymphocyte percentages [7 days]

   Serum Th9 lymphocyte percentages

2. Concentration of serum IL-9 [7 days]

   Concentration of serum IL-9

3. Concentration of serum iFABP [7 days]

   Concentration of serum iFABP

4. Concentration of serum DAO [7 days]

   Concentration of serum DAO

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nanjing First Hospital	Nanjing	Jiangsu	China	210000

Sponsors and Collaborators

• Nanjing First Hospital, Nanjing Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: XiangWang, Director, Nanjing First Hospital, Nanjing Medical University
• ClinicalTrials.gov Identifier: NCT03791866
• Other Study ID Numbers: YKK17102
• First Posted: Jan 3, 2019
• Last Update Posted: Jan 3, 2019
• Last Verified: Dec 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sepsis; Toxemia

Study Results

No Results Posted as of Jan 3, 2019