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

• Conditions: Syncope; Seizures
• Interventions: Diagnostic Test: Evalution of thyroid function

• Registration Number: NCT04879147
• Lead Sponsor: Ruhr University of Bochum

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.

Study Timeline

• Status Verified: 2021-05
• Study First Submitted: 2021-05-04
• Study First Submitted QC: 2021-05-04
• Study Start: 2021-05-05
• Study First Posted: 2021-05-10
• Last Update Submitted: 2021-05-19
• Last Update Posted: 2021-05-21
• Primary Completion: 2023-05-13
• Study Completion: 2024-05-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Syncope	Evalution of thyroid function	Subjects admitted immediately after syncopation.
Seizre	Evalution of thyroid function	Subject admitted immediately after cerebarl seizure

Primary Outcome Measures

Name	Time	Method
Prevalence of allostatic responses of thyroid function after short-term loss of consciousness	2 hours	Prevalence of increased TSH immediately after syncope or seizure

Secondary Outcome Measures

Name	Time	Method
Time series of thyroid function after short-term loss of consciousness	72 hours	Temporal evolution of TSH and thyroid hormone concentration during three days after syncope or seicure
Diagnostic value of TSH after short-term loss of consciousness	72 hours	Sensitivity, specificitay and likelihood ratios of TSH compared to free T4 and free T3 after syncopation or seizure

Trial Locations

Locations (4)

Institute of Clinical Chemistry, Transfusion and Laboratory Medicine, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum; 🇩🇪 Bochum, NRW, Germany

Medical Hospital I, Bergmannsheil University Hospitals, Ruhr University of Bochum; 🇩🇪 Bochum, NRW, Germany

Medical Hospital II, Bergmannsheil University Hospitals, Ruhr University of Bochum; 🇩🇪 Bochum, NRW, Germany

Neurological University Hospital and Clinics, Bergmannsheil University Hospitals, Ruhr University of Bochum; 🇩🇪 Bochum, NRW, Germany