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EN;NTIS: Investigating the Role of EN in NTIS Among Fistula Patients

Sponsor
Jinling Hospital, China (Other)
Overall Status
Completed
CT.gov ID
NCT02038504
Collaborator
(none)
40
Enrollment
1
Location
14.9
Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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.

    Study Design

    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 :
    Jan 1, 2013
    Actual Primary Completion Date :
    Apr 1, 2014
    Actual Study Completion Date :
    Apr 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    gastrointestinal fistula

    Outcome Measures

    Primary Outcome Measures

    1. Thyroid function [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of General Surgery, Jinling Hospital Nanjing Jiangsu China 210000

    Sponsors and Collaborators

    • Jinling Hospital, China

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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
    First Posted:
    Jan 16, 2014
    Last Update Posted:
    Jun 30, 2014
    Last Verified:
    Jun 1, 2014
    Keywords provided by Jianan Ren, VIce-president of General Surgery, Jinling Hospital, Professor of Medical School of Nanjing University, Jinling Hospital, China
    gastrointestinal fistula
    enteral nutrition
    thyroid function
    Additional relevant MeSH terms:
    Digestive System Fistula
    Fistula

    Study Results

    No Results Posted as of Jun 30, 2014