- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02038504
Investigating the Role of EN in NTIS Among Fistula Patients (EN;NTIS)
June 27, 2014 updated by: Jianan Ren, Jinling Hospital, China
a Prospective Study to Investigate the Role of Enteral Nutrition in Nonthyroidal Illness Syndrome Among Fistula Patients
The purpose of this study is to investigate whether enteral nutrition are effective in the treatment of nonthyroidal illness syndrome among fistula patients.
Study Overview
Status
Completed
Conditions
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
Enrollment (Actual)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Jiangsu
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Nanjing, Jiangsu, China, 210000
- Department of General Surgery, Jinling Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Department of general surgery in Jinling hospital
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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gastrointestinal fistula
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Thyroid function
Time Frame: Changes of thyroid function from baseline at 1 week,2 week, 3 week and 4 week after enrolled.
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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
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Changes of thyroid function from baseline at 1 week,2 week, 3 week and 4 week after enrolled.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
January 10, 2014
First Submitted That Met QC Criteria
January 14, 2014
First Posted (Estimate)
January 16, 2014
Study Record Updates
Last Update Posted (Estimate)
June 30, 2014
Last Update Submitted That Met QC Criteria
June 27, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NTIS-EN-1
- 81270478 (Other Identifier: National Natural Science Foundation of China)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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