NCT04450472

Brief Summary

Nonthyroidal illness syndrome (NTIS) is prevalent in critical illness; it is associated with poor outcomes. However, few studies have focused on the relationship between NTIS and short bowel syndrome (SBS). The aim of this study was to investigate the incidence, etiology, and prognosis of NTIS and its correlation in clinical variables in adult patients with SBS.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 31, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 29, 2020

Completed
Last Updated

June 29, 2020

Status Verified

June 1, 2020

Enrollment Period

2 years

First QC Date

June 25, 2020

Last Update Submit

June 25, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Thyroid function index

    Thyroid function assessment includes level of free triiodothyronine (FT3), total triiodothyronine (TT3), free thyroxin (FT4), total thyroxin (TT4), thyroid stimulating hormone (TSH).

    Within one week of patients enrollment.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with SBS admitted to a clinical nutrition center in a tertiary referral hospital were identified to evaluate the incidence of NTIS and to explore its correlation with clinical variables and prognosis in adult patients.

You may qualify if:

  • (1) Adult patients with SBS, defined as intestinal malabsorption disorder resulting from extensive bowel resection with a remnant small intestine length of greater than 200 cm, admitted to a clinical nutrition center.

You may not qualify if:

  • age less than 18 years;
  • previous history of thyroidal, hypophyseal or hypothalamic disease;
  • lactational or gestational period;
  • medication history of thyroidal hormone or antithyroid drugs;
  • craniocerebral injury;
  • attack of coronary heart disease, myocardial, or cerebral infarction in the past month;
  • intracranial infection or hemorrhage in the past month. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Short Bowel Syndrome

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the clinical nutrition center

Study Record Dates

First Submitted

June 25, 2020

First Posted

June 29, 2020

Study Start

December 31, 2016

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

June 29, 2020

Record last verified: 2020-06