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

NCT ID: NCT06154382

Last Updated: 2025-05-11

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 350 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2026-02-01

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

Conditions

Thyroid; Functional Disturbance

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

group 1: eltroxin administration

patients witn low T4 level who recieved eltroxin in ICU

Eltroxin administration

Intervention Type: DRUG

eltroxin administration

group 2: no eltroxin administration

patients witn low T4 level who did not recieve eltroxin in ICU

No interventions assigned to this group

Interventions

Eltroxin administration

eltroxin administration

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meir Medical Center

OTHER

Sponsor Role: lead

Responsible Party

sara dichtwald

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Meir Medical Center

Kfar Saba, , Israel

Site Status: RECRUITING

Countries

Israel

Facility Contacts

Sara Dichtwald, Dr.

Role: primary

sara.dichtwald@clalit.org.il

972-9-7472133 ext. 1

Other Identifiers

0290-23-MMC

Identifier Type: -

Identifier Source: org_study_id