Thyroid Hormone Supplementation in Patients With Septic Shock

Septic Shock Clinical Trial

Official title:

Triiodothyronine Hormone Supplementation Therapy in Patients With Septic Shock With Euthyroid Sick Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05270798
• Other study ID #: ESS
• Status: Completed
• Phase: Phase 2
• Start date: May 1, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: September 2023
• Source: Cantonal Hospital Zenica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary aim of the study would be to determine whether there is a difference in survival in the Intensive Care Unit between the group of patients with septic shock diagnosed with euthyroid sick syndrome who were treated with T3 hormone compared to the group of patients not treated with this hormone. Secondary objectives of the research would be:

Compare the level of thyroid hormones between the examined groups and

1. laboratory indicators of septic shock (C-reactive protein-CRP, procalcitonin, leukocytes, acid-base status, lactates)

2. APACHE II, SOFA and SAPS II patient assessment scales,

3. inflammatory prognostic systems (ratio of CRP and albumin-modified Glasgow prognostic score-mGPS, ratio of neutrophils and lymphocytes - NLR, ratio of platelets and lymphocytes - PLR, and ratio of leukocytes and CRP, prognostic index - PI)

4. hemodynamic stability of patients (MAP, systolic and diastolic pressure) in the periods of admission T0, T3, T6, T12, T24 and every 24 hours for 4 days,

5. effect of vasoactive drugs,

6. the need for mechanical ventilation categorized as yes or no, in case - number of respirator days,

7. length of stay in the Intensive Care Unit,

8. treatment outcome categorized as 28 day survival.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• all patients who meet the criteria for septic shock according to the definition of Surviving sepsis campaigning (The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA 2016): persistent hypotension requiring the use of vasoactive drugs to maintain mean arterial pressure =65 mm Hg ; blood lactates> 2 mmol / L despite adequate resuscitation volume,

• patients with laboratory-proven euthyroid sick syndrome, according to diagnostic criteria which include: normal levels of TSH hormone, low levels of T3 hormone that may accompany low levels of T4 hormone (depending on the stage of critical disease) and absence of previous primary thyroid and pituitary disease.

Exclusion Criteria:

• age below 18,

• patients with a history of thyroid disease or an enlarged thyroid gland,

• psychiatric patients,

• patients on hormone therapy (excluding insulin),

• those taking amiodarone, corticosteroids or dopamine

• pregnant or postpartum mothers 6 months ago,

• patients who refuse to participate in the study

Related Conditions & MeSH terms

• Euthyroid Sick Syndromes
• Septic Shock
• Shock
• Shock, Septic
• Syndrome

Intervention

Drug:
• triiodothyronine
Patients in septic shock who meet the diagnostic criteria for euthyroid sick syndrome will be divided into two groups; patients with low T3 levels and patients with low T3 and T4 levels. Both of these groups will be further randomly divided into patients receiving T3 hormone and patients receiving placebo.

Locations

Country	Name	City	State
Bosnia and Herzegovina	Cantonal Hospital	Zenica

Sponsors (1)

Lead Sponsor	Collaborator
Cantonal Hospital Zenica

Country where clinical trial is conducted

Bosnia and Herzegovina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference in survival in the Intensive Care Unit between the groups of patients with septic shock diagnosed with euthyroid sick syndrome who were treated with T3 hormone compared to the group of patients who were not treated with this hormone.		28 days