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Observational and Diagnostical Study on Transient Allostatic Responses of Thyroid Function After Syncopation and Seizure

Observational and Diagnostical Study on Transient Allostatic Responses of Thyroid Function After Syncopation and Seizure (Thyro-Syncope)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04879147
Acronym
Thyro-Syncope
Enrollment
350
Registered
2021-05-10
Start date
2021-05-05
Completion date
2024-05-13
Last updated
2021-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seizures, Syncope

Keywords

thyroid allostasis, TACITUS, syncope, seizure, loss of consciousness

Brief summary

Changes of thyroid function may occur after short loss of consciousness, but they haven't been systematically evaluated up to now, although occasional observations suggest temporal increases in TSH concentration. This study aims at assessing transient changes of biomarkers of thyroid function after syncopation and seizure. Results of the study might contribute to an improved detection rate of thyrotoxicosis.

Detailed description

Transient allostatic responses of thyroid function have been described in critical illness. Own observations suggest similar reactive responses after syncopation and cerebral seizures. They are marked especially by increased concentration of serum thyrotropin (TSH), suggesting a type 2 allostatic response. However, changes of thyroid function after temporal loss of consciousness haven't been systematically evaluated up to now. Current diagnostic guidelines recommend primarily the determination of serum TSH concentration for screening of thyroid function, and the measurement of peripheral thyroid hormones (T4 and/or T3) is only recommended if TSH determination results in pathological values. This TSH reflex strategy may be misleading after short-term loss of consciousness. This study aims at assessing the prevalence of allostatic responses of thyroid function after events of syncopation or seizure and at investigating the consecutive temporal development of biomarkers of thyroid function. An additional aim includes the diagnostic value of TSH determination, compared to measurement of free thyroid hormones, for thyroid dysfunction after syncopation or seizure. Results of this study might contribute to an improved detection rate of thyrotoxicosis. In cases of medical emergencies and in-patient treatment interventions with a significant iodine load are common, including the application of iodinated radiocontrast agents and amiodarone. In this setting, undetected hyperthyroidism may lead to thyroid storm, which is associated with a high mortality.

Interventions

DIAGNOSTIC_TESTEvalution of thyroid function

Determination of TSH, free T4, free T3, SPINA-GT, SPINA-GD and Jostel's TSH index

Sponsors

Bergmannsheil University Hospitals
CollaboratorUNKNOWN
Ruhr University of Bochum
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Admission after syncope or seizure * Age of 18 years or older * First bleed not later than two hours after event (syncope or seizure) * Written informed consent obtained

Exclusion criteria

* Results of thyroid hormones not available within two hours after event * Pituitary dysfunction * Thyroid dysfunction * Use of iodinated radiocontrast agents less than three months ago * Therapy with amiodarone in the previous three years * Pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of allostatic responses of thyroid function after short-term loss of consciousness2 hoursPrevalence of increased TSH immediately after syncope or seizure

Secondary

MeasureTime frameDescription
Time series of thyroid function after short-term loss of consciousness72 hoursTemporal evolution of TSH and thyroid hormone concentration during three days after syncope or seicure
Diagnostic value of TSH after short-term loss of consciousness72 hoursSensitivity, specificitay and likelihood ratios of TSH compared to free T4 and free T3 after syncopation or seizure

Countries

Germany

Contacts

Primary ContactJohannes W Dietrich, M.D.
johannes.dietrich@ruhr-uni-bochum.de+49-234-302
Backup ContactMatthias Sczesny-Kaiser, M.D.
matthias.sczesny-kaiser@bergmannsheil.de+49-234-302

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026