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NCT06154382 | NOT YET RECRUITING | Thyroid; Functional Disturbance

Eltroxin Administration to Patients With Extremely Low T4 Values in the Intensive Care Unit
Sponsor:

Meir Medical Center

Information provided by (Responsible Party):

Sara Dichtwald

Brief Summary:

Nonthyroidal illness (formerly called sick euthyroid syndrome) is a common condition in patients hospitalized in the intensive care unit, and it is caused by changes in the levels of thyroid hormones in the blood . These changes are correlated to the severity of the critical illness, morbidity and mortality. This condition is characterized by low serum T3 levels, high rT3 levels, normal or low T4 levels, and normal or low TSH levels. Previous studies have shown a relationship between NTIS (nonthyroidal illness) and poor therapeutic outcomes in patients admitted with sepsis, multi trauma, ARDS, acute respiratory failure, septic shock and mechanically ventilated patients in intensive care . In general, the recommendation is not to routinely take blood tests to evaluate thyroid function in critical patients in the intensive care unit, unless they were previously known to have a thyroid disease or there is a clinical suspicion that such a disorder developed during hospitalization in the intensive care unit. Also, studies so far have not shown an advantage for eltroxin administration to intensive care patients with low T3 and/or T4 levels when the laboratory tests indicate NTIS. However, there is a specific group of patients, with NTIS and extremely low T4 levels (less than 50% of the lower limit of the normal range) who have a particularly high mortality rate in intensive care (over 85%) and in whom it has not been investigated whether the administration of eltroxin will improve the therapeutic outcomes ( , i.e. was such a low T4 level in them considered a marker for the severity of their general critical illness, or is it another disorder in itself, the treatment of which would benefit the patient) . We would like to examine whether the administration of eltroxin in this specific group of patients, which has not been studied so far, will be beneficial in improving the therapeutic outcomes

Condition or disease

Thyroid; Functional Disturbance

Intervention/treatment

Eltroxin administration

Study Type : OBSERVATIONAL
Estimated Enrollment : 350 participants
Official Title : Eltroxin Administration to Patients With Extremely Low T4 Values in the Intensive Care Unit: Comparison Between Groups and Therapeutic Outcomes
Actual Study Start Date : 2024-06-01
Estimated Primary Completion Date : 2026-02-01
Estimated Study Completion Date : 2026-02-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 99 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria: All patients aged 18--99 who were admitted to the general intensive care unit from January 2016 to November 22, 2023 for any reason, and who during their hospitalization in the intensive care unit had lower than normal T4 levels measured. It is about 350 patients. Of these, we will specifically examine the group of patients for whom an extremely low level of T4 was measured (less than 50% of the lower limit of the norm).
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    • Exclusion Criteria: Patients who were known to have a chronic thyroid dysfunction prior to their hospitalization in the unit, patients who were regularly treated with eltroxin prior to their hospitalization
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    • Eltroxin Administration to Patients With Extremely Low T4 Values in the Intensive Care Unit

    Location Details

    NCT06154382

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    Locations

    Not yet recruiting

    Israel,

    Meir Medical Center

    Beyon Kfar Saba, Israel,