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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

Tracking Information
First Submitted Date January 10, 2014
First Posted Date January 16, 2014
Last Update Posted Date June 30, 2014
Study Start Date January 2013
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 14, 2014)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Investigating the Role of EN in NTIS Among Fistula Patients
Official Title a Prospective Study to Investigate the Role of Enteral Nutrition in Nonthyroidal Illness Syndrome Among Fistula Patients
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
whole blood
Sampling Method Non-Probability Sample
Study Population Department of general surgery in Jinling hospital
Condition Gastrointestinal Fistula
Intervention Not Provided
Study Groups/Cohorts gastrointestinal fistula
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 27, 2014)
40
Original Estimated Enrollment
 (submitted: January 14, 2014)
30
Actual Study Completion Date April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT02038504
Other Study ID Numbers NTIS-EN-1
81270478 ( Other Identifier: National Natural Science Foundation of China )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jianan Ren, Jinling Hospital, China
Study Sponsor Jinling Hospital, China
Collaborators Not Provided
Investigators Not Provided
PRS Account Jinling Hospital, China
Verification Date June 2014