Investigating the Role of EN in NTIS Among Fistula Patients

Gastrointestinal Fistula Clinical Trial

— EN;NTIS  

Official title:

a Prospective Study to Investigate the Role of Enteral Nutrition in Nonthyroidal Illness Syndrome Among Fistula Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02038504
• Other study ID #: NTIS-EN-1
• Secondary ID: 81270478
• Status: Completed
• Phase: N/A
• First received: January 10, 2014
• Last updated: June 27, 2014
• Start date: January 2013
• Est. completion date: April 2014

Study information

• Verified date: June 2014
• Source: Jinling Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to investigate whether enteral nutrition are effective in the treatment of nonthyroidal illness syndrome among fistula patients.

Description:

Nonthyroidal illness syndrome (NTIS) is a common alterations in thyroid function observed in about 70% of hospitalized patients, with or without acute systemic illnesses. Mechanisms in the pathogenesis of NTIS are not yet well understood. Our previous study demonstrated that NTIS occurred frequently with a prevalence of 57.5% in gastrointestinal fistulas patients. In recent study, it has been shown that early enteral nutrition decreases the duration of hospitalization and mortality in the burn population, indicating a potential role of enteral nutrition in NTIS.In addition, the management of fistula patients requires bundle therapy including Nutrition therapy, especially enteral nutrition.The purpose of this study is to investigate whether enteral nutrition are effective in the treatment of nonthyroidal illness syndrome among fistula patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of gastrointestinal fistula

• Clinical diagnosis of nonthyroidal illness syndrome

• Using enteral nutrition for fistula management

Exclusion Criteria:

• patients who were prescribed drug which may affect thyroid function before or in our study

• patients who were diagnosed as primary thyroid disease

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Digestive System Fistula
• Fistula
• Gastrointestinal Fistula

Locations

Country	Name	City	State
China	Department of General Surgery, Jinling Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jinling Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thyroid function	Thyroid function assessment includes level of free triiodothyronine,total triiodothyronine,free thyroxin,total thyroxin,thyroid stimulating hormone,thyroid stimulating hormone index,and standard thyroid stimulating hormone index	Changes of thyroid function from baseline at 1 week,2 week, 3 week and 4 week after enrolled.	No