Serum Thyroid Function After Iodinated Contrast Administration

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05786846

Collaborator

(none)

400

Enrollment

Location

9.5

Anticipated Duration (Months)

42.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study investigated the changes in serum thyroid function and urinary iodine levels before and after the use of iodinated contrast to analyze the prevalence of thyroid dysfunction in the Chinese euthyroid adults after using iodinated contrast.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Dysfunction	Drug: Iodinated contrast agents

Detailed Description

This study aims to monitor the thyroid function, urinary iodine level, and other indicators of patients after using iodine contrast agents, in order to analyze the prevalence of thyroid dysfunction after using iodine containing contrast agents, and investigate the impact of different iodine contrast agents on thyroid function, in order to provide evidence for the use of iodine contrast agents in clinical practice and the risk prevention of subsequent thyroid diseases.

Study Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Serum Thyroid Function After Iodinated Contrast Administration in Chinese Euthyroid Adults: a Prospective Observational Study.

Actual Study Start Date :

Feb 15, 2023

Anticipated Primary Completion Date :

Jul 31, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Outcome Measures

Primary Outcome Measures

Incidence rate of thyroid dysfunction after administration of iodine contrast agent. [up to 32 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

patients who use iodinated contrast agent

Exclusion Criteria:

patients with the following diseases: malignant tumor, critical illness (admitted to ICU), mental disease, hypothalamus-pituitary disease.
administration of anti-thyroid drugs (methimazole, propylthiouracil), levothyroxine, compound iodine solution, amiodarone, immunostaining point inhibitor, tyrosine kinase inhibitor, interferon, interleukin-6, lithium, glucocorticoids β Receptor blockers, dopamine, dobutamine, bromocriptine, octreotide, phenobarbital, phenytoin sodium, rifampicin, and carbamazepine within the past 6 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sun Yat-Sen Memorial Hospital	Guangzhou		China

Sponsors and Collaborators

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Investigators

Study Director: Li Yan, Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

ClinicalTrials.gov Identifier:

NCT05786846

Other Study ID Numbers:

SYSEC-KY-KS-2022-002

First Posted:

Mar 28, 2023

Last Update Posted:

Mar 28, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Thyroid Diseases

Study Results

No Results Posted as of Mar 28, 2023