Eltroxin Administration to Patients With Extremely Low T4 Values in the Intensive Care Unit
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Eltroxin administration.
- Who it may be relevant to
- Registry conditions: Thyroid; Functional Disturbance. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Eltroxin Administration to Patients With Extremely Low T4 Values in the Intensive Care Unit: Comparison Between Groups and Therapeutic Outcomes
Overview
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
Interventions
- Drug Eltroxin administration
eltroxin administration
Primary outcome measures
- 28-day mortality [Time frame: 28-day mortality]
Eligibility 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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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Israel · 1 center
- Meir Medical Center — Kfar Saba
Identifiers
NCT: NCT06154382 · 0290-23-MMC