Clinical trial NCT04879147: Observational and Diagnostical Study on Transient Allostatic Responses of Thyroid Function After Syncopation and Seizure
Official title: Observational and Diagnostical Study on Transient Allostatic Responses of Thyroid Function After Syncopation and Seizure (Thyro-Syncope)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Syncope
Seizures
Keywords: thyroid allostasis
TACITUS
syncope
seizure
loss of consciousness
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
Collaborators: name: Bergmannsheil University Hospitals
First posted: 2021-05-10
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible are subjects addmitted for in-patient treatment after syncope or cerebral seicure

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of allostatic responses of thyroid function after short-term loss of consciousness
timeFrame: 2 hours
Secondary outcomes:
measure: Time series of thyroid function after short-term loss of consciousness
timeFrame: 72 hours
measure: Diagnostic value of TSH after short-term loss of consciousness
timeFrame: 72 hours
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Institute of Clinical Chemistry, Transfusion and Laboratory Medicine, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum
state: NRW
city: Bochum
country: Germany
facility: Medical Hospital I, Bergmannsheil University Hospitals, Ruhr University of Bochum
state: NRW
city: Bochum
country: Germany
facility: Medical Hospital II, Bergmannsheil University Hospitals, Ruhr University of Bochum
state: NRW
city: Bochum
country: Germany
facility: Neurological University Hospital and Clinics, Bergmannsheil University Hospitals, Ruhr University of Bochum
state: NRW
Study officials:
affiliation: Bergmannsheil University Hospitals
name: Johannes W Dietrich, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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