Thyroid Hormone Supplementation in Patients With Septic Shock

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.

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Key information

Conditions

Euthyroid Sick Syndromes Endocrine System Diseases Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome Thyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cantonal Hospital

Zenica, 72000, Bosnia and Herzegovina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Triiodothyronine

Drug

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.

Primary outcomes

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.

Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Cantonal Hospital Zenica

Other

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Mar 8, 2022
Registry last updated: Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed