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Investigating the Role of EN in NTIS Among Fistula Patients (EN;NTIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02038504
Recruitment Status : Completed
First Posted : January 16, 2014
Last Update Posted : June 30, 2014
Sponsor:
Information provided by (Responsible Party):
Jianan Ren, Jinling Hospital, China

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

Condition or disease
Gastrointestinal Fistula

Detailed 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.

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: a Prospective Study to Investigate the Role of Enteral Nutrition in Nonthyroidal Illness Syndrome Among Fistula Patients
Study Start Date : January 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Group/Cohort
gastrointestinal fistula



Primary Outcome Measures :
  1. Thyroid function [ Time Frame: Changes of thyroid function from baseline at 1 week,2 week, 3 week and 4 week after enrolled. ]
    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


Biospecimen Retention:   Samples Without DNA
whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Department of general surgery in Jinling hospital
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02038504


Locations
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China, Jiangsu
Department of General Surgery, Jinling Hospital
Nanjing, Jiangsu, China, 210000
Sponsors and Collaborators
Jinling Hospital, China
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Responsible Party: Jianan Ren, VIce-president of General Surgery, Jinling Hospital, Professor of Medical School of Nanjing University, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT02038504    
Other Study ID Numbers: NTIS-EN-1
81270478 ( Other Identifier: National Natural Science Foundation of China )
First Posted: January 16, 2014    Key Record Dates
Last Update Posted: June 30, 2014
Last Verified: June 2014
Keywords provided by Jianan Ren, Jinling Hospital, China:
gastrointestinal fistula
enteral nutrition
thyroid function
Additional relevant MeSH terms:
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Digestive System Fistula
Fistula
Pathological Conditions, Anatomical
Digestive System Diseases